Position Purpose:
The Manufacturing Sciences group at Leadiant Biosciences is responsible for the technical and scientific oversight of manufacturing operations for all marketed products, including routine commercial manufacturing activities, technology transfers, and process and equipment validations. The group works externally with contract manufacturers and internally with all levels of the organization to ensure delivery of a consistent and reliable supply of drug product that meets GMP specifications over the product lifecycle.
Under the direction of the Senior Manager, Manufacturing Sciences, the Senior Associate will coordinate manufacturing activities carried out by contract manufacturers for assigned commercial products. The position will support process investigations for manufacturing-related issues and is expected to evaluate and resolve technical problems of moderate complexity. The Senior Associate will also support continuous improvement initiatives by researching products/processes identified as needing improvement, recommending strategies for improvement, and supporting the implementation of those strategies once approved.
Essential Functions:
- Supports the Senior Manager, Manufacturing Sciences, with the technical and scientific oversight of manufacturing operations for assigned marketed products.
- Works with external contacts (contract manufacturers, contract labs, etc.) and collaborates cross-functionally with Leadiant Quality Assurance, Supply Chain Regulatory Affairs, Regulatory Sciences, and Regulatory CMC within the Scientific Affairs groups to ensure the timely execution of cGMP activities in manufacturing operations.
- Functions as a technical and scientific resource in support of manufacturing activities at Contract Manufacturing Organizations (CMOs). Leverages technical expertise in support of manufacturing process evaluations, technology transfers, process validations, training, regulatory/CMC support, and in support of Health Authority inspections.
- Working with Project Managers and the Product Development group, assist in setting milestones and monitoring progress for assigned projects. Communicate assignments and deadlines to contract facilities as needed and follow-up on open items consistently.
- Engages with contract manufacturers, contract labs, and/or consultants to troubleshoot and effectively resolve technical and scientific problems using engineering and scientific principles.
- Actively participates in investigations of deviations and variations in manufacturing and/or packaging that relate to equipment and process issues. Contributes to the development and implementation of corrective actions to unplanned (atypical) manufacturing events.
- Supports investigations into product technical complaints.
- Compiles process and product data obtained from contract manufacturers and ensures that data are formatted appropriately for analysis.
- Assesses the technical and operational feasibility of change controls for assigned products in a timely manner.
- Actively participates in the creation and revision of production documentation, protocols, reports and other GMP documents by contract manufacturers. Reviews and provides feedback on validation and manufacturing procedures, master batch records, protocols, and CMC studies.
- Contributes to the production portion of the Chemistry, Manufacturing, and Controls (CMC) section of regulatory submissions and attends regulatory meetings as the technical product owner.
- Reports on the status of commercial manufacturing activities and any open investigations at internal meetings. May periodically present on the status of major projects to the Senior Leadership Team.
- Assists with the design and execution of shipping validation studies.
- Coordinates finished product logistics and release with Supply Chain and QA, respectively.
Specific Job Knowledge, Skill and Ability:
- BS/BA or Associates Degree in biological sciences, chemical sciences, engineering or equivalent technical discipline. Individuals with a Quality Assurance background will also be considered provided that they have the technical and scientific expertise needed for the position.
- Some experience with Biologics is preferred but not required.
- At least 3 years of related industry experience required. Knowledge of pharmaceutical product development, manufacturing processes, validation, cGMP’s and FDA regulations for the pharmaceutical industry.
- Significant experience with interfacing with commercial CMOs is preferred. This could include commercial product technical transfer, validation, and/or change control support.
- Must have good organization, prioritization and follow-up skills.
- Experience with and understanding of statistics and statistical methods a plus.
- Demonstrated ability to collaborate with cross functional teams to manage processes and implement process improvements.
- Experience authoring and reviewing technical reports, standard operating procedures, work instructions, and other controlled documents.
- Working knowledge of Quality Systems such as Deviation, CAPA, Change Control Systems.
- Solid proficiency in the use of Microsoft software (word processing, email, spreadsheet, database, and Internet).
- Excellent communication skills with an ability to effectively communicate at all levels of an organization, both internal and external.
Travel Requirements:
Must be able to travel 10-15% of the time.
Leadiant Biosciences, Inc. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, and other legally protected characteristics. The EEO is the Law poster is available here: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.
If you need a reasonable accommodation because of a disability for any part of the employment process, please send an e-mail to Jobs@leadiant.com and let us know the nature of your request and your contact information.
