Job Summary: 

• Manufacturing detection kit components, kits, and ancillary products.
• Manufacturing of buffers, controls, and calibrators using cGMPs
• Transacting and closing out work orders using QAD Enterprising Applications.
• Acts independently to determine methods and procedures for new assignments.
• Perform troubleshooting and manage product issues.
• Interface with other departments to ensure the product is delivered on-time.
• Performs analytical and functional testing of products.
• Maintains and analyzes lot histories for trends and discrepancies.
• Write, review, and modify SOPs for PCOs/DCOs
• Investigate and resolve NCARs/CAPA.
• Conduct manufacturing accounting/work order transactions
• Keeps department lead or supervisors updated on all issues.
• Actively supports continuous improvement efforts, PPI, Lean, and 5-S programs.
• Reviewing batch records and other documents.

Skills on Resume: 

• Kit Manufacturing (Hard Skills)
• Buffer and Calibrator Production (Hard Skills)
• QAD Work Order Management (Hard Skills)
• Problem-Solving (Soft Skills)
• Troubleshooting (Hard Skills)
• Cross-Team Collaboration (Soft Skills)
• Process Improvement (Soft Skills)
• Document Review (Hard Skills)

Job Summary: 

• Plan and carry out formulation development work under the supervision of the formulation group leader
• Under the general guidance, independently carry out analysis of the raw materials, APIs, excipients, and drug products with all needed methods
• Follow the study guide, carry out studies to collect data, and report results to the group leader and upper management team
• Create and revise technical reports and maintain appropriate laboratory records
• Initiate and generate ideas based on reading and research
• Assist in devising new formulations and refining existing ones, and transfer to the partner for drug product formulation
• Optimize the process by DOE and QbD methods, and scale up the formulation studies to pilot and production scale
• Propose an improvement based on the formulation studies
• Maintain and modify the related instruments and equipment
• Oversee hardware development and acquisition needed for formulation and PD work
• Work with different departments of the company at various stages of drug product development

Skills on Resume: 

• Formulation Development (Hard Skills)
• Raw Material Analysis (Hard Skills)
• Data Reporting (Hard Skills)
• Report Writing (Hard Skills)
• Research and Innovation (Soft Skills)
• Process Optimization (Hard Skills)
• Equipment Maintenance (Hard Skills)
• Cross-Team Collaboration (Soft Skills)

Job Summary: 

• Develop new formulations/products and new methods/product line extensions for Encapsys.
• Apply scientific principles and practices to develop new products and technologies in support of business objectives.
• Document and communicate research results, conclusions, and recommendations through internal reports and meetings.
• Work with outside technology experts to ensure deliverables are met.
• Interface with customers to resolve complaints, institutionalize new processes, and develop specifications to continually meet their needs.
• Prepare formulations according to specified criteria and processing methods.
• Develop an understanding of key chemical and process variables affecting results.
• Stay abreast of emerging technical developments in the broader scientific community.
• Record results of laboratory tests and maintain records of procedures performed on each test.
• Observe the performance of standardized testing for adherence to prescribed methodology, including observation of safe testing methods and procedures.
• Acquire, set up, adjust, and maintain laboratory equipment and instruments.
• Review needs and requirements for new or replacement testing, processing, and analytical equipment.
• Work collaboratively with Manufacturing, R&D, and EH&S to implement and support product design initiatives.

Skills on Resume: 

• Formulation Development (Hard Skills)
• Research Application (Hard Skills)
• Data Documentation (Hard Skills)
• Customer Support (Soft Skills)
• Process Improvement (Hard Skills)
• Equipment Maintenance (Hard Skills)
• Team Collaboration (Soft Skills)
• Technical Awareness (Soft Skills)

Job Summary: 

• Involved in pre-clinical, clinical, and/or post-marketing stages of drug development.
• Participates in the development of scientific strategy
• Coordinates the development of methods and processes that meet or exceed the expectations of clients and provide innovation
• Guides and advises during the implementation of new methodologies and processes
• Be viewed as a Subject Matter Expert to solve problems related to the conduct of chemical experiments.
• Develops realistic proposals and timelines
• Leads multiple projects independently, including managing project timelines and deliverables.
• Leads technical discussions with clients and presents recommendations to clients and internal teams.
• Liaises with internal scientific, analytical, and laboratory functional areas to meet project and team objectives.
• Be a valued member of a team committed to advancing the design of manufacturing processes and solving problems with innovative solutions.
• Coordinates research of industry practices and processes and applies them to innovative development internally and for client products.
• Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
• Maintains the necessary compliance status required by the company and facility standards

Skills on Resume: 

• Drug Development (Hard Skills)
• Scientific Strategy (Soft Skills)
• Method Development (Hard Skills)
• Process Innovation (Hard Skills)
• Project Management (Soft Skills)
• Client Communication (Soft Skills)
• Industry Research (Hard Skills)
• Regulatory Compliance (Hard Skills)

Job Summary: 

• Designing and performing customer-driven development projects on the formulation of pharmaceutical and consumer healthcare products (liquid fill and shell formulations)
• Conducting pre-formulation studies in the lab
• Supporting and driving the process development team during the pilot-scale manufacturing phase
• Supporting the Regulatory Team in preparing the modules during the product filing process
• Understanding Quality by Design principles to prepare formulation development risk assessments, protocols, and reports
• Supporting customers through the formulation development process and giving guidance on formulation development plans
• Coordinating lab logistics (raw materials, samples, shipments)
• Preparing manufacturing protocols for trial runs
• Keeping up to date with regulatory and pharmacopeia requirements (ICH/FDA)
• Working under cGLP/cGMP guidelines

Skills on Resume: 

• Formulation Development (Hard Skills)
• Pre-Formulation Studies (Hard Skills)
• Process Development Support (Hard Skills)
• Regulatory Support (Hard Skills)
• Quality by Design (Hard Skills)
• Customer Guidance (Soft Skills)
• Lab Logistics Coordination (Hard Skills)
• Regulatory Compliance (Hard Skills)

Job Summary: 

• Lead or support multi-functional project teams.
• Interact with various internal and external disciplines.
• Independently plan, prioritize, and conduct experimental work
• Leads R&D efforts in formulation development projects as a technical expert or technical lead.
• Establishes standard operating procedures for the formulation and processing of new products.
• Designs experimental plans and test protocols required to evaluate parameters of new and existing formulations and processes
• Assists in the scale-up and qualification of new manufacturing processes.
• Authors' reports, internal/corporate technical documentation, and external scientific publications.
• Communicates results and impact with project directors, R&D management, and business leaders.
• Develops a comprehensive understanding of intellectual property through submission of invention disclosures and supporting legal documentation through office action responses
• Creates and maintains project documentation, and assists in projects delivered on time and within project budget.
• Complies with all job-related safety, security, and other training requirements

Skills on Resume: 

• Project Leadership (Soft Skills)
• Cross-Functional Collaboration (Soft Skills)
• Experimental Planning (Hard Skills)
• Formulation Development (Hard Skills)
• Process Scale-Up (Hard Skills)
• Technical Documentation (Hard Skills)
• Intellectual Property Management (Hard Skills)
• Regulatory Compliance (Hard Skills)

Job Summary: 

• Develops and optimizes liquid formulations for commercial, clinical, and preclinical products toward high potency, safety, and stability.
• Develops and optimizes lyophilized formulations for commercial, clinical, and preclinical products toward high potency, safety, and stability.
• Develops and optimizes lyophilization recipes/processes
• Performs formulation/lyophilization robustness studies, freeze/thaw studies, and DoE
• Performs basic analytical methods for the analysis of formulation trials
• Work closely in a cross-functional team with the Upstream, Downstream, Drug Product, and Analytical groups in the Process and Manufacturing Sciences Department.
• Prepares technical reports and maintains cGLP/cGMP-sound documentation.
• Maintains documentation of experiments and/or protocols according to good documentation practices
• Point person for formulation-related technology transfer
• Interaction with CMOs on formulation/lyophilization
• Support regulatory filings
• Troubleshoots and problem-solves to initiate and execute/monitor corrective actions
• Maintain lab supplies and instruments according to formulation activities

Skills on Resume: 

• Liquid Formulation (Hard Skills)
• Lyophilization (Hard Skills)
• Process Optimization (Hard Skills)
• Analytical Testing (Hard Skills)
• Team Collaboration (Soft Skills)
• Regulatory Support (Hard Skills)
• Problem-Solving (Soft Skills)
• Lab Maintenance (Hard Skills)

Job Summary: 

• Maintain a safe and effective operational environment in the laboratory, staying current with HSE training and complying with all the HSE rules and regulations in daily operation
• Manage laboratory chemicals, supplies, and ancillary equipment by ensuring the supplies are properly stocked and organized, and the ancillary equipment is properly calibrated
• Work with lab automation experts to digitize the workflow, improving operational work cycle time based on digital improvements (i.e., D360 and Benching)
• Formulation support for Discovery PK studies
• Perform formulation screening, prepare/characterize dosing formulations for animal studies
• Conduct HPLC method development and sample analysis of small molecules
• Measure the protein concentration of monoclonal antibodies
• Troubleshoot analytical instrumentation and solve technical problems
• Conduct formulation research and process improvement, interpret results, and write technical reports
• General laboratory maintenance, buffer preparations, labeling, and shipping
• Order materials for in vivo rodent screening PK studies

Skills on Resume: 

• Lab Safety (Hard Skills)
• Supply Management (Hard Skills)
• Workflow Automation (Hard Skills)
• Formulation Support (Hard Skills)
• HPLC Development (Hard Skills)
• Protein Analysis (Hard Skills)
• Instrumentation Troubleshooting (Hard Skills)
• Process Improvement (Soft Skills)

Job Summary: 

• Follow QbD methodology and sound scientific principles to develop robust, scalable products
• Develop protocols, generate data, and prepare product development reports to support development, Regulatory submissions, or validation in a compliant manner
• Secondary SME for regulatory and customer audits and technical meetings on clinical trials, formulation/process development, and technology transfer to Manufacturing
• Primary product development person for the company’s projects and technical contact for client communication
• Collaborate with Analytical R&D and other cross-functional teams for the timely completion and accurate interpretation of scientific data
• Draft SOPs for laboratory and assay procedures
• Prepare concise, sound scientific presentations of study results to the management team
• Co-author scientific technical reports.
• Quality Testing and qualifying the material.
• Assisting in the final packaging process (folding packaging inserts and inserting finished goods into Kit packaging, etc.)
• Validations and process improvement activities
• Cross-training in all aspects of Immunohistochemistry formulation and manufacturing.
• Handling multiple projects and priorities at the same time.

Skills on Resume: 

• QbD Methodology (Hard Skills)
• Regulatory Documentation (Hard Skills)
• Technical Audits Support (Hard Skills)
• Client Communication (Soft Skills)
• Cross-Functional Collaboration (Soft Skills)
• SOP Drafting (Hard Skills)
• Scientific Reporting (Hard Skills)
• Process Improvement (Soft Skills)

Job Summary: 

• Identify new business opportunities and growth areas together with cross-functional teams based on market needs and technical trends.
• Translate these needs into technical programs to meet business targets.
• Lead New Product Introductions and execute technology programs to drive short- and long-term business growth strategy.
• Execute projects by closely collaborating and communicating across functions, across the globe with customers, and with business management.
• Develop and maintain competitive and patent landscapes for NORYL products and technologies.
• Develop and maintain Intellectual Property covering new technologies.
• Ensure activities are compliant with safety and regulatory requirements.
• Actively participate in organizational citizenship, such as recruiting, mentoring, and community interactions
• Lead or contribute as a member of Six Sigma problem-solving teams.
• Provide manufacturing support on new products and processes.
• Guide and support during product validation and scale-up.
• Improve products/processes through collaboration with external research organizations, end-use customers, and key suppliers.

Skills on Resume: 

• Business Growth (Soft Skills)
• Technical Development (Hard Skills)
• Product Introduction (Hard Skills)
• Team Collaboration (Soft Skills)
• IP Management (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Six Sigma (Hard Skills)
• Manufacturing Support (Hard Skills)

Job Summary: 

• Request, file, and evaluate RM documents, MBRs, Processes, and equipment.
• Support clients by performing nitrosamine risk assessments of all products in alignment with regulatory requirements and timelines
• Support customers to perform confirmatory testing and changes to the ANDA filing if warranted
• Maintain and amend the documentation created throughout the lifespan of each product.
• Create Ingredient Disclosures for each commercial and developmental product
• Participate in evaluating formulations, equipment, and processes.
• Write and ensure timely execution of protocols and development reports for feasibility work and manufacturing batch records, and clinical trial materials following current Good Manufacturing Practices and company standards.
• Participate in relevant meetings/teleconferences with clients.
• Develop realistic proposals and timelines.
• Assist with new product development and build knowledge and experience in both new processing technologies and product formulation
• Work independently under direction from senior product development scientists on various tasks
• Assist with creating and maintaining formulations, specifications, processes, and testing procedures
• Assist with line trials within the manufacturing facilities, collect data, and assess process and quality parameters to ensure the finished product meets targets and/or specifications
• Stays current with new pharmaceutical ingredients, products, and processing technologies

Skills on Resume: 

• Document Management (Hard Skills)
• Risk Assessment (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Formulation Evaluation (Hard Skills)
• Protocol Writing (Hard Skills)
• Client Communication (Soft Skills)
• New Product Development (Hard Skills)
• Process Improvement (Soft Skills)

Job Summary: 

• Develop briefs, technical specifications, and technical documentation for product application development.
• Understand key requirements of customers and develop a portfolio of product applications such as RTD Coffees, Teas (Iced Tea and Teabags), Cold Brews, etc
• Create product applications and prototypes with novel ingredients from Olam and present them to customers to work collaboratively with business development teams for commercialization.
• Undertake product demos with customers, gather feedback used in prototyping, and work with flavor houses to develop flavors as required by the customers.
• Develop protocols and Standard Operating Procedures (SOPs) for undertaking laboratory prototyping and scale-up of applications to pilot scale or work with 3rd parties or customers to scale up and commercialize products.
• Use techniques of flavor and taste modulation and design formulations that deliver bio-actives within cost parameters desired by customers.
• Develop sensory evaluation methods and generate data that will be reliable and replicable from prototyping to scale-up.
• Manage product catalog, sampling, and inventory, and ensure the safety of product samples to customers.
• Maintain laboratory equipment critical to application work within the laboratory.
• Undertake shelf-life studies for ingredients or product applications.
• Develop product labels that will meet the regulatory and nutritional declarations using Genesis or other systems meeting product specifications.
• Collaborate with origin teams, and marketing & sales teams to create collaterals for product marketing and customer-centric sales opportunities.
• Listen and engage with customers to understand their jobs to be done and collaborate efficiently.
• Work with a team of chefs and creative specialists to develop ideas and prototypes and present them to customers.

Skills on Resume: 

• Technical Documentation (Hard Skills)
• Product Application Development (Hard Skills)
• Prototyping and Formulation (Hard Skills)
• Customer Collaboration (Soft Skills)
• SOP Development (Hard Skills)
• Sensory Evaluation (Hard Skills)
• Inventory Management (Hard Skills)
• Regulatory Compliance (Hard Skills)

Job Summary: 

• Design and perform formulation and process development of solid dosage forms applying QbD principles, following the applicable guidelines (ICH, EHS, GMP standards), and in close cooperation with the analytical development department
• Collaborate in the creation of drug product development concepts from discussion with clients and transfer into the development and/or production area
• Collaborate in strategic meetings with clients, support scientific marketing activities in the context of scientific publications, articles, white papers, webinars, and conferences
• Collaborate with the NPIx Operations to transfer the developed drug product to GMP Manufacturing while working closely with Operations, Regulatory Affairs, Quality departments, and Project Management
• Collaborate in the preparation of submission dossiers
• Support the selection and implementation of new technologies
• Responsibility for the immediate demonstration of safety defects in the systems and equipment falls to the head of production, and close cooperation with the EHS department
• Perform formulation development and stability assessment activities for biological drug candidates, including monoclonal antibodies (mAb), antibody-drug conjugates (ADC), bispecific antibodies, and fusion proteins, to enable clinical study and product commercialization.
• Design and execute studies evaluating the chemical and physical stability of biologics in various formulation buffers (pH, ionic strength, stabilizing additives) under proper study conditions (accelerated temperature, mechanical stress, etc.) for product shelf-life stability
• Address manufacturing process-related product stability (freeze-thaw, mixing, filtration and filling, etc.).
• Apply combined theoretical models and utilize experimental results to aid the development of a robust drug product manufacturing control strategy.

Skills on Resume: 

• Formulation Development (Hard Skills)
• Process Development (Hard Skills)
• Client Collaboration (Soft Skills)
• Regulatory Support (Hard Skills)
• Technology Implementation (Hard Skills)
• Safety Compliance (Hard Skills)
• Stability Testing (Hard Skills)
• Process Optimization (Hard Skills)

Job Summary: 

• Lead development and optimization of exosome therapeutic formulations for exosome-packaged small molecules, RNAs, or oligos currently in preclinical development.
• Perform analytical method development for small molecules using analytical tools, including HPLC (method development, operation, and maintenance), UV-VIS, fluorescence spectrometers, LC/MS, etc.
• Develop assays to assess the stability and storage of therapeutic exosome formulations.
• Maintain organized documentation of experimental results and protocols, and support the development and documentation of methods intended for research, GxP, and clinical studies.
• Execute in-house assay characterization and optimization studies to facilitate scale-up and tech transfer to and from CROs.
• Actively collaborate with other scientists to understand key product requirements and develop methods in-house.
• Represent the formulation sciences team in cross-functional meetings and prepare and present data to all team members.
• Maintain thought leadership with the current exosome therapy ecosystem and bring best practices to Mantra.
• Develop strategies for formulation and process development and the corresponding regulatory submissions.
• Collaborate within the CMC team, actively contribute to deliverables, and engage in team discussions on issue resolution.
• Execute and oversee development, scale-up, and clinical manufacture at external drug product GMP facilities.
• Draft and review presentations relevant to formulation development activities and present them to the CMC team.
• Author and review technical reports, regulatory filings, source documents, and external publications.

Skills on Resume: 

• Exosome Formulation (Hard Skills)
• Analytical Development (Hard Skills)
• Stability Testing (Hard Skills)
• Data Documentation (Hard Skills)
• Assay Optimization (Hard Skills)
• Team Collaboration (Soft Skills)
• Regulatory Strategy (Hard Skills)
• Tech Transfer (Hard Skills)

Job Summary: 

• Plan, execute, and/or direct a variety of research and development projects for new or improved/innovative formulations. 
• Responsible for formulation development activities through all stages of the project development, including preliminary formulations for efficacy testing, formulation optimization, and processing studies
• Establish formulation for regulatory studies and EPA registration, scale-up, and commercial production. 
• Exercise judgment within defined procedures and practices to select methods and techniques for obtaining results.
• Provide technical support services to Manufacturing, FMD, Marketing, and Sales to solve technical problems or customer complaints related to formulations.
• Work with Formulation Manager, other Formulation Chemists, and Technology Managers to plan and set objectives and timelines for development projects for new or improved/innovative formulations. 
• Interact with external companies’ formulation chemists, consultants, and industry personnel regarding research, development, and alternative technologies for formulation improvements. 
• Maintain and expand knowledge and expertise in all aspects of formulation research and development.
• Communicate effectively, both orally and in writing, with the Formulation Manager to ensure that projects are progressing on track and meet objectives and timelines
• Provide information on formulation project status and results, get and understand information on priorities, resolve problems or issues, coordinate activities, and obtain feedback and needed information or assistance.
• Follows safety and regulatory plans, and waste disposal procedures. 
• Participates in all required safety meetings and training programs.

Skills on Resume: 

• Formulation Development (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Scale-Up and Production (Hard Skills)
• Technical Problem-Solving (Soft Skills)
• Project Planning (Soft Skills)
• External Collaboration (Soft Skills)
• Data Communication (Soft Skills)
• Safety Compliance (Hard Skills)