Astellas Pharma Bioprocess Engineer II, Manufacturing Science & Technology in Westborough, Massachusetts
Bioprocess engineer II, Manufacturing Science & Technology
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 of 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 engineer II, Manufacturing Science & Technology opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA.
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 new product processes & new technology introduction to GMP operations. The incumbent will focus on product requirements, process efficiencies, and the installation and integration of new equipment. Based on specified requirements evaluate and implement new technology. In addition, this role will establish systems to assess process performance, identify/implement process improvements, and perform process verification and validation studies.
Essential Job Responsibilities:
Lead new process or technology transfer from internal and external partners into GMP manufacturing department focusing on evaluation of manufacturing processes (Drug Substance, Drug Product and Cell banking), equipment/systems and facilities meeting required criteria and specifications of the intended production.
Lead generation of product and process specific user requirements for equipment qualifications
Provide input on equipment qualification documents (IQ/OQ/PQ).
Establish and utilize appropriate statistical tools to characterize equipment and process input/output relationships including capturing critical process parameters and key product attributes, perform risk assessment during tech transfer and monitor tech transfer progress.
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.
Author and update technical and manufacturing documents necessary for investigations, continuous process improvement and process demonstrations.
Manage laboratory equipment to ensure proper operation & maintenance.
Perform data mining and analysis from executed batch records to assess and monitor GMP manufacturing process and support root cause analysis
Project Leader for internal or cross-functional projects.
Provide guidance and oversee the activities of other lower-level personnel.
Creates a positive work environment promoting teamwork, mutual respect, encouraging change, innovation, and accountability at all levels
- Report directly to Director of Manufacturing Science and Technology (MS&T)
BS/MS in bioengineering, chemical/pharmaceutical engineering or biology field with at least 10+ years for BS, 7+ years for MS, & 3+ years for Ph.D. in a biotechnology, cell therapy or pharmaceutical manufacturing environment.
Experience with cGMP manufacturing, process 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.
Biologics experience required with cell therapy knowledge preferred.
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 project 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 and Sick time, plus national holidays including year-end shut down
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
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
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