Bioprocess Lead II
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
Astellas Institute for Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.
Astellas is announcing a Bioprocess Lead II opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.
As a member AIRM’s Manufacturing (MFG) team, the Bioprocess Lead II will play a critical role in the execution of manufacturing’s technology transfer program and completing quality deliverables associated with them. These major job functions include the responsibility to drive change controls to introduce new product in AIRM, investigating deviations, and Corrective and Preventive Actions (CAPAs) to completion as well as implement continuous improvements at AIRM’s quality system. This role is critical in ensuring the success for manufacturing campaigns, this can be achieved by leading planning, scheduling, and key aspects for operations with team members, and members of cross-functions to meet milestones.
This position will supervise a sub-team in MFG. Candidate in this role is expected to have strategic and critical thinking alongside abilities to identify trends and patterns in GMP manufacturing operations. This individual is expected to be an independent leader in a matrix organization.
Essential Job Responsibilities:
Manage operators’ skills training through creating training plans and qualification strategies for new incoming drug product manufacturing processes, providing constructive feedback, and documenting/monitoring progress.
Oversee the progress of operations as a Subject Matter Expert (SME).
Identify gaps and develop new trainings as needed for the GMP operations.
In collaboration with Manufacturing Tech Support (MTS) team perform MFG training impact assessments for New Product Introduction (NPI) and propose changes/modifications to training program based on new technology/process requirements.
Lead high level investigations.
Propose and Implement CAPAs.
Lead Change Controls as related to Manufacturing such as New Product Introduction, New Technology introduction, Process Change including impact assessments by proposed changes, etc.
Track and trend patterns to identify potential gaps, issues and implement appropriate corrections.
Technology Transfer (50%)
Lead new product and technology transfers per NPI SOP representing Manufacturing team such as developing timelines for milestones, working on readiness of Cleanrooms/equipment, and performing gap assessments.
Continuously monitor the progress of projects and anticipate/propose the needs of tasks done to meet the milestones.
Support/propose strategic approaches for the projects.
Collaborate with Manufacturing Science and Technology (MS&T), Process Science and Technology (PST) and Drug Product Development (DPD) teams to build expertise (SME Status) on new products/processes.
Involve in process optimization for manufacturing logistic improvement working closely with MS&T.
Represent MFG on cross-functional tech transfer meetings.
Lead generation of required Master Batch records (MBRs) and Standard Operating Procedures (SOPs) from writing drafts to approval.
Analyze and summarize manufacturing data generated such as in-process testes. Interpretate the data as needed.
Continuous Improvements (20%)
Lead complicated or large Continuous Improvement projects collaboratively or independently to meet cGMP compliances.
Lead a sub-group by supervising MFG associates job performances.
Motivate and inspire the team to do their best work.
This is a high impact high visibility role that impacts production pipeline (Portfolio).
This individual will be key in successful NPIs at AIRM. Failure to meet timelines and program objectives can adversely affect clinical programs.
- Directly reports to the Director of Cell Manufacturing. Supervises associates.
Bachelors (Science or Engineering): > 7 years
Masters/PhD :>3 years
Experience in Manufacturing, Engineering and/or Quality environment (pharmaceutical or medical device industry preferred)
Experience in NPI/Tech Transfers.
Experienced in Drug Substance (Cell Culture) and Drug Product operations.
Experience with visual inspection of drug product.
Experience in quality management systems for Deviations, Change Controls, MBR and SOP drafting.
Strong oral, written communication, and interpersonal skills.
Experience with project management methodologies to create schedules and planning.
Strategic thinker with critical analysis capabilities.
Complex problem solver.
Experience in people management
Process optimization on Cell Therapy Products – Drug Substance (Cell Culture) and Drug Product.
Understanding of change management and project management methodologies
Proficiency utilizing MS Office products.
Detail oriented with good organizational skills and documentation practices.
Able to manage priorities and maintain timelines for multiple projects in a fast pace setting.
Ability to work effectively independently, as well as part of a team.
Experience with continuous improvement and/or operational excellence (OpEx) is highly desirable.
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including 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