MANUFACTURING ASSOCIATE JOB DESCRIPTION

Batch records close only when every step is executed correctly. A single missed deviation in a cGMP production run can trigger a product hold, delay a clinical trial supply, or prompt a regulatory audit. The Manufacturing Associate exists to prevent that outcome, executing aseptic processing, equipment operation, and SOP-driven documentation within cleanroom and large-scale bioreactor environments governed by FDA cGMP and GXP requirements. Few entry-to-mid-level roles put a person this close to regulated product release decisions this early in a career.

As the Manufacturing Associate, you execute production-scale manufacturing operations - from reagent fill-finish and Clean-In-Place procedures to batch record completion - ensuring that clinical and commercial pharmaceutical products meet cGMP release standards. You work within a cross-functional production team that spans quality, engineering, and process development, with work scope extending across rotating shifts in controlled cleanroom or large-scale bioproduction settings.

Career Impact: Experience operating under FDA cGMP and GXP frameworks at production scale is a credential that carries weight across pharmaceutical, biotech, and contract manufacturing organizations, accelerating advancement toward senior technician or process engineer roles.

Business Impact: The products leaving this role's production area supply clinical trials and commercial patient populations, meaning accurate batch execution and timely deviation escalation directly affect drug availability for end users.

Growth Opportunity: Associates who build cross-training depth in fermentation, purification, and aseptic fill-finish position themselves for promotion into lead operator, process development technician, or manufacturing supervisor tracks within two to four years.

• Execute production operations including aseptic processing, Clean-In-Place, and equipment sterilization within cGMP-regulated cleanroom environments.
• Complete batch records, logbooks, and electronic transaction documentation accurately for every production step per SOP requirements.
• Monitor manufacturing equipment during runs and escalate deviations, variances, or process anomalies to supervision with supporting documentation.
• Maintain inventory of production components, consumables, and ancillary equipment to sustain uninterrupted manufacturing throughput.
• Perform routine equipment cleaning, preventive maintenance, and calibration checks to keep production assets within validated parameters.
• Support deviation investigations and participate in continuous improvement activities to reduce process variability.
• Train incoming operators on procedures of moderate complexity under the direction of senior manufacturing personnel.
• Coordinate material receipt, identification, and staging using established material management systems to ensure supply chain traceability.

• High school diploma or GED required, or Associate's or Bachelor's degree in a life sciences field preferred.
• 2 or more years of manufacturing or laboratory experience, with demonstrated exposure to cGMP or GXP regulated production environments.
• Ability to read, interpret, and execute written SOPs, batch record steps, and work instructions without deviation.
• Demonstrated competency in accurate documentation including data entry, logbook recording, and electronic transaction completion.
• Physical capability to lift up to 50 pounds, stand for shifts of 10 or more hours, and work in cold room environments as required.
• Willingness to work rotating shifts including nights, weekends, and scheduled holidays to meet production demand.
• Strong attention to detail with the ability to identify and escalate subtle process variances before they become deviations.
• Effective verbal and written communication skills sufficient to coordinate with quality, engineering, and operations stakeholders.

• Prior cleanroom or aseptic processing experience, including gowning qualification in an ISO-classified environment.
• Familiarity with large-scale bioreactor production operations including cell culture, fermentation, or purification unit operations.
• Experience executing fill-finish, heat-sealing, or tube-capping operations for reagent or pharmaceutical consumable products.
• Demonstrated ability to author or revise controlled documents such as SOPs or batch record steps under a change control process.

• Batch record completion rate, measuring the percentage of production batches closed without documentation errors or missing entries.
• Deviation count per production run, tracking how often process anomalies are escalated before product impact occurs.
• Equipment downtime attributable to missed maintenance steps, reflecting adherence to preventive maintenance and cleaning schedules.
• Training completion rate for assigned SOPs, indicating readiness to operate independently across qualified unit operations.
• On-time batch release contribution, measuring this associate's documentation turnaround against production release timelines.
• Typical tools: manufacturing execution systems (commonly batch record platforms and electronic logbook systems); material management systems (commonly ERP-based inventory and goods-receipt modules).

• Base Salary Range: $38,000 to $58,000 per year depending on seniority and shift differential.
• Bonus: Shift differential pay common; annual performance bonus of 3 to 5% at some employers.
• Equity: Rarely offered at this level; possible at biotech startups pre-IPO.
• Health Benefits: Medical, dental, and vision coverage; employer contribution typically 70 to 85%.
• PTO: 10 to 15 days annually plus paid holidays; some employers offer additional shift-based leave.
• Common Perks: Tuition reimbursement for life sciences coursework, safety boot and PPE allowances, on-site cafeteria at larger sites.

Figures are estimates based on general US market benchmarks and may be outdated. Adjust based on location, company size, and seniority level.

Reasonable accommodations are available to qualified individuals with disabilities throughout the application and employment process in accordance with the Americans with Disabilities Act. Employment in this role is contingent upon successful completion of a background check and, where applicable, a pre-employment drug screening consistent with the regulated nature of pharmaceutical manufacturing. All persons must be authorized to work in the United States. All qualified applicants are considered without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other characteristic protected by applicable federal, state, or local law.

The Manufacturing Associate owns the assembly, soldering, and fabrication of mechanical parts and products to required specifications within a Raytheon Missiles & Defense production line. Working alongside a team committed to continuous improvement, this role supports quality standards and safe manufacturing operations that directly enable defense product delivery.

Key Responsibilities

• Read, understand, and interpret work instructions to complete assembly of products or components according to established guidelines and quality standards.
• Read, learn, understand, and comply with safety and Raytheon Missiles & Defense process and procedures.
• Use a variety of hand and power tools following appropriate methods and procedures to complete mechanical assembly of components or products.
• Report problems with quality, processes, equipment, and materials to Supervisor.
• Maintain a clean, organized, and safe work area to facilitate manufacturing functions.
• Practice problem solving and troubleshooting techniques as part of a team responsible for continuous improvement.
• Perform quality work checks to ensure product meets quality standards.
• Identify product defects and complete appropriate documentation when defects are identified.
• Rework and/or repair assembled product according to engineering specification changes.
• Maintain inventory of products in work areas and cross train to other departments as needed.

Required Qualifications

• 9+ months of directly related experience in the defense industry required.
• Must successfully demonstrate Raytheon Missiles & Defense Values and Behaviors through the interview process.
• Experience working with Microsoft Office, online communication, LMS, Qualification Tracking, PRISM, and/or like systems.
• Collaboration skills including teaming, attention to detail, and self-motivation.
• Accountability demonstrated through good attendance, positive job performance, and ability to follow directions.
• Ability to frequently sit, stand, and walk for up to 10 hours; reach, stoop, kneel, and crouch.
• Ability to regularly lift and move up to 25 pounds.
• Specific vision abilities including close, distance, and peripheral vision and color perception.

Reporting to production leadership, the Manufacturing Associate delivers electro-mechanical assembly of base ATM units by installing, wiring, and configuring components to customer specifications within a North Canton, OH production facility. Partnering with quality and operations teams, this role ensures consistent throughput and conformance that supports on-time customer order fulfillment.

Core Functions

• Identify and assemble components such as switches, relays, transformers, motors, gears, pulleys, solenoids, PC boards, cables, sheet metal parts, and control panels.
• Layout and perform complete wiring and cabling of the assembly.
• Check and/or test completed assemblies for conformance to specifications, including adjustment and repair as required.
• Follow all assembly instructions outlined in a computer-based Manufacturing Execution System to ensure proper assembly.
• Test sub-component parts using test software and perform all quality checks outlined in the Manufacturing Execution System.
• Operate hand and power tools and test equipment; handle material in and around work area and keep it clean and orderly.
• Maintain consistent throughput of product within written and visual specifications.
• Understand and obey all Company Safety Procedures and SOPs including PPE requirements.
• Perform other duties as assigned or required.

Qualifications & Experience

• High School diploma or GED required.
• Previous production and assembler experience preferred; ability to read schematics preferred.
• Basic math, grammar, and communication skills.
• Ability to work with little to no supervision applying a wide variety of procedures.
• Punctuality and work readiness per Employee Handbook; ability to follow Company Policies and Procedures.
• Ability to bend, twist, stretch, push, pull, carry, and lift up to 50 pounds; comfortable standing or walking for long periods.
• Ability to work various shifts and overtime as required.

Embedded within the Gresham production facility, the Manufacturing Associate builds boxes, packs chocolate bars into caddies, and applies labels to meet daily manufacturing demand across two facility locations. Working closely with production and quality teams, this role ensures CGMP compliance and accurate data recording that sustains consistent output and food safety standards.

Primary Duties

• Complete scheduled production and/or packaging assignments per daily schedule while meeting or exceeding set standards.
• Follow work processes and procedures accurately and consistently.
• Accurately record all required data for the job.
• Follow all policies required by CGMP (Current Good Manufacturing Practices).
• Participate in daily, weekly, and monthly cleaning tasks and monthly inventory.

Skills & Qualifications

• Basic food manufacturing experience required.
• Ability to work with basic math computations and use a scale to compute product weights.
• Ability to use labeling programs on a computer.
• Ability to communicate necessary job-related information in a professional and timely manner.
• Ability to perform all work-related duties in English.
• Ability to sit or stand in one place for up to three hours; frequent lifting of 1–10 pounds; infrequent lifting or pushing up to 50 pounds.

Reporting to lab operations leadership, the Manufacturing Associate shapes consumable production by running semi-automated reagent fillers, heat-sealing systems, and tube capper equipment at scale within the Sorrento Valley manufacturing facility. Partnering with cross-functional teams across EH&S and process development, this role enables a reliable supply of high-quality reagent consumables that support both internal and external product needs.

Duties

• Run semi-automated reagent filler and heat-sealing systems; perform hand-fill and use tube capper systems to produce reagent consumable cartridges and tubes.
• Assemble and package final products into boxes and apply labels.
• Produce high quality consumables using a variety of equipment and processes as scale-up occurs.
• Maintain excellent production records; execute batch records and SOPs and provide input on documentation improvements.
• Monitor and maintain inventory of consumables parts needed for production.
• Assist in day-to-day setup and running of lab operations in accordance with all EH&S programs.
• Keep equipment operational by following protocols/SOPs; perform routine maintenance, testing, and calibration of lab equipment.
• Cross train in flow cell assembly processes if scale-up needs arise.

Experience & Qualifications

• Bachelor of Science or Associate's degree in a scientific field preferred.
• 0–2 years of relevant manufacturing laboratory experience preferred.
• Experience in fill finish and packaging manufacturing desired; experience in GMP labs a plus.
• Experience using a pipette and working with liquid reagents; experience following SOPs and batch records.
• Experience operating semi-automated lab equipment using equipment interfaces or control software.
• Self-motivated with ability to organize and prioritize multiple tasks; highly organized and flexible.
• Ability to lift, carry, and handle up to 30 lbs safely.

A key member of the Herman Miller production team, the Manufacturing Associate leads assembly of products and related parts at a standard rate driven by customer demand and Lean manufacturing principles. Collaborating across workstations and departments, this role contributes to on-time delivery of high-quality furniture products while actively participating in HMPS continuous improvement activities.

Functions

• Assemble parts and/or products according to standardized work.
• Complete required paperwork correctly to ensure record accuracy.
• Know and practice corporate, plant, and department safety and quality guidelines.
• Maintain a clean, safe working environment according to 5S and department safety guidelines.
• Maintain flexibility to meet team, department, and plant goals.
• Participate in Herman Miller Performance System (HMPS) improvement activities within current or other departments.
• Perform a minimum of 75 percent of department jobs at the required rate; rotate through workstations based on business need.
• Commit to meeting overtime requirements and perform additional responsibilities as requested.

Education & Experience

• High school diploma or equivalent (GED) or work experience demonstrating performance competency.
• Competency in basic math skills such as adding and subtracting.
• Ability to read, understand, communicate, and interpret written and verbal instructions in English.
• Ability to bend, twist, and stand for periods of up to 10 or 12 hours; ability to lift up to 40 pounds.
• Ability to work cooperatively within the team and with other teams to meet goals.
• Demonstrated willingness to adapt to a continually changing environment and commitment to team success through reliable attendance.
• Flexibility to work varied assignments and hours as business needs require.

Consistent pharmaceutical product quality and manufacturing throughput depend on the Manufacturing Associate, who executes process monitoring, material handling, and packaging operations using mechanical apparatus, automated equipment, and manual processes in a GMP environment. Based within a cross-functional operations team, this role sustains audit-ready compliance and uninterrupted supply by accurately managing SAP transactions, batch records, and inventory.

Accountabilities

• Perform material handling, staging, ordering, returning, and goods receipt; execute manual tasks including feeding, dispensing, charging, mixing, sorting, inspecting, assembling, and picking.
• Execute manufacturing and packaging operations using mechanical apparatus, automated equipment, and manual processes.
• Accurately complete paperwork and electronic transactions for all documentation including SAP transactions, batch record steps, and logbooks.
• Perform final checks and verifications for operations as indicated in batch records and SOPs.
• Operate forklift, manual, and motorized pallet jacks; maintain proper inventory levels of clean tools and ancillary equipment.
• Manage waste removal and execute equipment cleaning and housekeeping in accordance with policies and procedures.
• Work with the team to ensure all aspects of the business remain compliant and audit-ready.
• Order and receive material and perform required identification using the RFI system and basic SAP.

Minimum Qualifications

• High School Diploma or GED required; Bachelor's Degree required if fewer than 2 years of relevant experience.
• Minimum of 2 years of relevant experience preferred; pharmaceutical/GMP experience preferred.
• Previous experience in a manufacturing environment preferred.
• Proven ability to interact with operators, management, and cross-functional groups.
• Proficient in Microsoft Word and Excel required; working knowledge of Production Automation Systems (Wonderware, MES, SAP) required.
• Ability to continuously lift and/or move 5–25 lbs and frequently lift or move 25–50 lbs.

As the Manufacturing Associate, this role executes aseptic processing of birth tissue in a controlled cleanroom environment, including solution preparation, equipment cleaning, and production controls to meet cGMP quality standards. The operations team relies on this work to maintain FEFO compliance, validated process parameters, and a safe biohazard-managed facility that supports consistent tissue product quality.

Activities

• Perform aseptic processing of birth tissue in a cleanroom environment, including processing area setup and changeover.
• Prepare solutions used for aseptic processing and maintain aseptic and neat work environment.
• Perform equipment cleaning and general equipment maintenance; record data following cGMP requirements.
• Complete requisitions for test samples and submit to designated labs; execute production controls including inspection steps to ensure product quality standards are met.
• Ensure materials and processes follow FEFO and that processes are completed within validated parameters.
• Assist with troubleshooting process issues; handle biohazard waste following all safety guidelines.
• Prepare disinfectants, perform facility sanitization/cleaning, and perform general office duties as needed.

Background & Experience

• High school diploma or equivalent required; Bachelor's or Associate's degree in biological sciences or related field preferred.
• 1–3 years of laboratory experience preferred; 1–3 years of cleanroom experience preferred.
• Basic proficiency in Microsoft Office applications (Excel, Word, PowerPoint, Outlook) required.
• Excellent verbal and written communication skills in English.
• Ability to multi-task and set priorities effectively in a fast-paced environment.
• Self-motivated and able to work with minimal supervision.

Manufacturing Associate delivers cGMP-compliant operation of complex biotech systems and equipment at large scale, including fermentation, purification cross-training, deviation investigations, and authoring of new procedures within a Genzyme manufacturing environment. The work directly supports a culture of compliance and continuous improvement by training junior staff and modeling the organizational values of honesty, accountability, and sound judgment.

Operational Focus

• Operate complex systems and equipment under minimal supervision in strict accordance with cGMPs, SOPs, and safety guidelines.
• Perform and/or direct preliminary troubleshooting activities; solicit direction from senior personnel as needed.
• Train less experienced or new staff on procedures and may provide work direction to lower-level staff.
• Author new procedures of moderate complexity and revise current procedures.
• Execute cross-training with fermentation and purification; assist with deviation investigations.
• Act as a role model by demonstrating honesty, respect, accountability, and sound judgment in all dealings.

Professional Experience

• High School Diploma or equivalent with 5+ years of experience, or B.S. degree or biotechnology certificate with 2+ years of cGMP large-scale production experience.
• Large or small-scale bioreactor production experience highly preferred.
• Good technical writing and troubleshooting skills; strong attention to detail and developed communication skills.
• Ability to lift up to 50 pounds and work with hazardous materials as required.
• Willingness to work weekends or overtime to meet production standards.

The Manufacturing Associate produces machined seal components by setting up seal machines, processing parts, and verifying dimensions against blueprint specifications using precision measurement tools in a seal manufacturing environment. Working within lean and 5S+ frameworks, this role maintains accurate SPC documentation and production line logs that uphold quality control and continuous improvement objectives.

Job Functions

• Log on to the computer and scan work order; read process sheet and blueprint for the work order.
• Set up seal machines in the cell by adding tooling to the machines.
• Process parts through machining.
• Measure seals using tools such as micrometers, pi tape, gauges, and verniers by checking dimensions as indicated on blueprints.
• Document and control dimensions using SPC (Statistical Process Control).
• Participate in lean and 5S+ activities; complete and maintain production line logs.
• Perform other related duties as assigned.

Position Requirements

• High School Diploma or GED from an accredited institution required.
• Minimum of 1 year of work experience required.
• Must be able to work in the United States without corporate sponsorship now and in the future.
• This position is subject to ITAR; all applicants must be U.S. persons as defined by ITAR (U.S. Citizen, Permanent Resident, Political Asylee, or Refugee).
• Only candidates within a 50-mile radius of Beltsville, MD will be considered; no relocation benefit offered (Active Duty Military candidates exempt from geographic limitation).

Reporting to manufacturing management, the Manufacturing Associate refines the intake, cataloguing, and coordination of manufacturing documentation, batch sheets, and logbooks across all functional groups to ensure timelines are consistently met. Partnering with document owners throughout the organization, this role maintains repositories and prepares progress reports that give leadership clear visibility into documentation compliance.

Day-to-Day Responsibilities

• Enter information into departmental databases and perform intake review of manufacturing documents for completeness and accuracy.
• Facilitate and catalogue manufacturing documentation, records, batch sheets, and logbooks.
• Ensure documentation timelines are met through effective communication and follow-through with document owners.
• Coordinate document movement across all functional groups and implement and maintain document repositories.
• Prepare routine progress reports on manufacturing documentation for management.

Knowledge Skills & Abilities

• Leaving certificate or equivalent with 2+ years of relevant administrative and data entry work experience required.
• Experience in a GMP, SOP, ISO, or similar regulated environment strongly desirable.
• Proficient in Microsoft Word, Excel, PowerPoint, and Outlook; PC literate with prior experience in MS systems.
• Excellent verbal and written communication skills.
• Ability to work effectively within a team and demonstrate a can-do attitude.

Sitting at the intersection of clinical manufacturing and process development, the Manufacturing Associate produces cell therapy products under GMP in a controlled cleanroom environment while supporting raw material testing, SOP authoring, and equipment maintenance. Operating across a cross-functional team of scientists, engineers, and bioinformatic specialists, this role directly enables the advancement of Aspen Neuroscience's clinical programs.

Role Responsibilities

• Manufacture clinical cell therapy product under GMP in a controlled cleanroom environment.
• Maintain equipment and inventory for manufacturing and process development operations.
• Perform testing and release of raw materials and new reagent lots; identify and comparatively test alternative tissue culture material and reagent sources working with QC.
• Support a Process Engineer in manufacturing cell lots for process and assay development.
• Write standard operating procedures, batch records, and quality documents.
• Work within a cross-functional team of scientists, engineers, bioinformatic specialists, and research associates.
• Perform other duties and responsibilities as assigned.

Technical Qualifications

• Bachelor's Degree in Cell Biology, Molecular Biology, Chemistry, or related science required.
• Experience in a GMP manufacturing environment required.
• Aseptic tissue culture of mammalian cells required; pluripotent stem cell experience is a plus.
• Strong organizational and documentation skills required.
• Must be willing to work flexible hours.

Embedded within a clinical and commercial pharmaceutical production team, the Manufacturing Associate advances cGMP-compliant manufacturing by operating and monitoring equipment, executing Clean-In-Place and sterilization processes, and performing final packaging and inspection of pharmaceutical products. Working closely with supporting functional groups, this role troubleshoots equipment issues and provides procedural improvement feedback that sustains uninterrupted product supply.

What You'll Do

• Perform Clean-In-Place, Clean-Out-of-Place, and equipment sterilization operations.
• Operate and monitor manufacturing equipment for the production of clinical and commercial pharmaceutical products under minimal supervision.
• Execute routine and complex production processes; troubleshoot manufacturing equipment in conjunction with supporting functional groups.
• Perform final packaging and inspection of pharmaceutical products.
• Receive and distribute supplies in the manufacturing area.
• Provide feedback to manager on recommendations for procedural and process improvements.
• Perform all other duties as assigned.

Education & Experience

• High School diploma or equivalent with 5–8 years of experience, or Biotechnology Certificate or Associate's Degree in a science-related field with 3–5 years of experience required.
• Bachelor's Degree in Physical or Chemical Sciences or related Engineering field with 1–3 years of experience preferred.
• Experience with operating automated manufacturing control systems preferred
• Experience utilizing parts washers and autoclaves for preparation of manufacturing and/or laboratory equipment.
• Ability to sit, stand, and walk regularly; occasionally lift 0–15 pounds.

A key member of the Allergan production team, the Manufacturing Associate builds electro-mechanical assemblies and sub-assemblies for medical device products by following released procedures, performing in-process inspections, and completing all cGMP documentation within a regulated manufacturing environment. Collaborating across assemblers, technicians, QA personnel, and engineers, this role sustains on-time delivery and high-quality output that meets customer and regulatory standards.

Scope of Work

• Perform electro-mechanical assembly of final products, sub-assemblies, and related medical device products following released procedures.
• Perform tasks in the production and packaging of product to provide on-time delivery to customers; complete all required documentation accurately and on time.
• Perform in-process inspection to ensure products meet specifications and standards.
• Maintain a clean and organized work area during and at the end of each shift.
• Remain current on proper procedures by reviewing current, revised, and new SOPs and completing all required cGMP and safety training.
• Work in a team-oriented atmosphere with assemblers, technicians, QA personnel, and engineers, communicating effectively both orally and in writing.
• Assist with new product validations and work instruction evaluation builds; cross train to other product lines as needed.
• Perform other duties as assigned; must be available to work overtime including nights, weekends, and holidays as required.

Requirements

• High school degree or equivalent required; 1 year of manufacturing experience preferred.
• Previous experience in the medical device field and GMP regulated environment preferred.
• Strong mechanical skills; excellent hand-eye coordination, manual dexterity, and math skills.
• Ability to read and comprehend assembly instructions, SOPs, Bills of Materials, and production documentation in English.
• Basic knowledge of Windows-based computer systems such as Microsoft Office; ability to learn other computer-based systems.
• Ability to work any shift up to 12 hours including nights, weekends, and holidays as required.
• Physically able to continuously stand, walk, lift up to 25 pounds, and bend, climb, squat, stoop, and stretch frequently.

As the Manufacturing Associate, this role oversees complex electro-mechanical assembly, acceptance testing, and configure-to-order packaging of ultrasound equipment and accessories within a flexible manufacturing and operations group. The team relies on this work to fulfill customer orders accurately, maintain nonconforming material records, and develop junior associates through hands-on training and guidance.

Work Activities

• Perform complex but repetitive mechanical and electro-mechanical assembly and test operations under limited supervision.
• Use tools such as torque drivers, wrenches, measuring instruments, fixtures, and other hand-held tools.
• Follow verbal and written instructions including procedures, drawings, diagrams, and flow charts to complete assembly and subassembly tasks.
• Perform basic material handling, restocking, and cycle counting of components at workstation.
• Pick items from stockroom using part numbers on pick lists and package using work instructions to fulfill customer orders.
• Perform system-level final acceptance tests, configurations, and labeling using custom programs; log in and approve work completed and write up nonconforming material records.
• Provide training and guidance to other Manufacturing Associates; perform prototype work and assist in other areas as needed.

Experience & Qualifications

• High school diploma or equivalent required.
• Production experience in electro-mechanical, food, or other processes preferred.
• Experience working with computers and the Internet.
• Comfortable using computers to access information and run custom programs.
• Basic math skills including fractions and percentages.
• Excellent work ethics, personal responsibility, initiative, hand-eye coordination, manual dexterity, and attention to detail.
• Basic conversational and written English.
• Ability to frequently lift and carry a minimum of 40 lbs.
• Ability to work standing or walking for extended periods including an entire shift.

Manufacturing Associate produces high-quality pharmaceutical output by operating large-scale manufacturing equipment, performing cell culture, purification, and clean-in-place operations under cGMP guidelines within Sanofi's rotating-shift production environment. Success in the position means maintaining audit-ready documentation, training new operators, and applying manufacturing knowledge to drive continuous process improvements that support uninterrupted commercial supply.

Performance Expectations

• Practice and promote safe work habits; adhere to Sanofi's safety procedures and guidelines.
• Follow verbal and written procedures in operating production equipment and performing processing steps; accurately complete appropriate production documentation.
• Identify, escalate, and document events and variances that deviate from normal operation; participate in investigations as needed.
• Maintain cleanliness, orderliness, and supplies in the process area; perform clean-in-place operations.
• Prepare and operate large-scale manufacturing equipment and systems; perform batch record review, procedure revisions, and work order generation.
• Train less experienced or new operators; serve as lead operator on manufacturing operations as designated.
• Utilize manufacturing knowledge to improve process operations; troubleshoot basic mechanical operations.
• Perform cell culture, purification, and support services/solution prep; work rotating day and night shifts including holidays and weekends.

Qualifications & Experience

• High school diploma/GED with 3–5 years of experience in a cGXP manufacturing environment, or Bachelor's Degree with 1–3 years of experience.
• Extended experience in large-scale manufacturing operations; experience in a GXP environment and familiarity with Manufacturing Control Systems (e.g., DeltaV) preferred.
• Experience facilitating and delivering training and creating controlled documents.
• Proficiency in Microsoft Office applications.
• Ability to lift up to 50 lbs; ability to stand on average 10 hours per shift; ability to work in a cold room environment (2–10°C).
• Ability to work a 12-hour rotating shift including every other weekend and scheduled holidays; flexibility to work overtime as per business needs.

The Manufacturing Associate builds fluorescent nucleotides and related intermediates at production scale by performing organic synthesis, purification, and analytical methods including HPLC, NMR, MS, and UV-Vis within a production laboratory setting. Working alongside lab operations and EH&S stakeholders, this role sustains precise record keeping and SOP-driven workflows that directly enable a reliable supply of high-quality nucleotide compounds.

Key Deliverables

• Assist in synthesis and purification of in-house nucleotides and related intermediates according to protocols; ensure timely completion.
• Perform analytical methods including HPLC, NMR, MS, and UV-Vis for purity evaluation.
• Prepare reagent buffers with SOPs and carry out lab procedures and SOPs as required to support lab needs.
• Maintain excellent record keeping and documentation in line with a production environment.
• Produce high quality work with great attention to detail; operate in accordance with all EH&S requirements.
• Assist in day-to-day setup and running of lab operations.

Skills & Qualifications

• Bachelor of Science degree in Chemistry, Organic Chemistry, Pharmaceutical Chemistry, Biochemistry, or related scientific field required.
• 0–2 years of relevant manufacturing or research laboratory experience.
• Hands-on experience with wet organic chemistry (synthesis and purification) is a plus; hands-on experience with analytical or prep HPLC is a plus.
• Familiarity and hands-on experience with common laboratory equipment and techniques including pipets, vortex mixer, weigh balance, buffer preparation, and UV spectrophotometer.
• Strong written and verbal communication skills; self-starter with ability to organize and prioritize tasks independently.