Astellas Pharma Scientist II in Westborough, Massachusetts
Within AIRM’s Manufacturing Science and Technology (MS&T) team, the successful candidate will work closely with Process Development, Manufacturing, Engineering and Quality Assurance teams to lead introduction of new processes & new technologies from internal and external partners to GMP manufacturing department. The encumbent will focus on evaluation of manufacturing processes, gap analysis of material/equipment/systems between the sending and receiving units, documentions of tech transfer process and training of MFG associates of process-related techniques and use of new equipment. In addition, this role will establish systems to assess process performance, identify/implement process improvements, and perform studies to establish acceptable procession ranges.
Essential Job Responsibilities: List 10 or fewer primary duties and responsibilities for this position in order of importance and time spent. Include supervisory responsibilities. Focus on responsibilities rather than projects. Avoid being vague or listing many minor duties.
Lead new process or technology transfer from internal and external partners into GMP manufacturing department.
Perform evaluation of manufacturing processes and gap analysis of equipment and facilities to meet required criteria and specifications of the intended production.
Identify and evaluate criterial process parameters and assess criticality of quality attributes of materials and products. Optimizes procedures as needed to fit GMP production efficiently.
Establish and utilize appropriate statistical tools to characterize equipment and process input/output relationships including capturing critical process parameters and key product attributes.
Lead generation of product and process specific user requirements for equipment qualifications and provide input on equipment qualification documents (IQ/OQ/PQ).
Document tech transfer progress and author technical reports and other manufacturing documents necessary for investigations, continuous process improvement and process demonstrations.
Perform data mining/management and analysis from executed batch records to assess and monitor GMP manufacturing process and support root cause analysis.
Provide training activities to MFG associates during tech transfer process.
BS, MS, or Ph.D degree in biology, bioengineering, or related field with 10+ years for BS, 7+ years for MS, 2+ years for PhD in a biotechnology, cell therapy or pharmaceutical manufacturing environment.
Experience with cGMP manufacturing, automation and technology transfer preferred.
Proficient at small to medium scale process development with solid knowledge of cell biology, drug product/substance manufacturing and good aseptic skills.
Able to develop, revise, and review SOPs, protocols, batch records, process development and technical reports
Experience drafting and using FMEAs
Experience working within an Quality Management Systems including Non-Conformances, CAPA, Risk & Change Management (ISO 13485 / 21CFR820). · Excellent written and verbal communication skills with strong collaboration/ team building and organization skills to manage priorities and maintain timelines for multiple projects in a fast-pace setting.
Good knowledge of data management and statistical tools such as Design of Experiment (DoE)
Able to work flexible hours including weekends.
Strong knowledge & experience in process development & characterization, technology transfer & process validation activities.
In-depth technical and regulatory understanding of GMP biologics manufacturing, as well as applicable international regulations and standards in all phases of product development, including late stage through commercialization.
Experience with cell therapy manufacturing process a plus.
Experience performing continuous process monitoring, management of change control, deviations, and CAPAs in Quality systems.
Strong collaboration and team building, communication, and organizational skills.
Ability to author, review and approve technical documentation for process and design validations to verify compliance to technical specifications and standards.
Ability to engage cross-functional teams to facilitate the transfer of new production processes and execute implementation activities to support product launch.
The level of this position will be based on the final candidate’s qualifications.
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, national holidays, two Heritage Days, and Summer and Winter Breaks
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Category GMP Technical Operations
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans