Total Quality Analyst jobs in Worcester, MA

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 Technical Biopharma Manufacturing Scientist I opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA. This is an onsite position.

Purpose and Scope:

The successful candidate will work closely with Process Development, Manufacturing, Engineering and Quality Assurance teams to ensure successful introduction of new processes (NPI) & new technologies from internal and external partners to GMP manufacturing department. The incumbent will focus on evaluation of manufacturing processes, gap analysis of material/equipment/systems between the sending and receiving units, and training of MFG associates of process-related techniques and use of new equipment. The incumbent will also provide GMP Technical Training during new employee on-boarding process to ensure operation proficiency and compliance. The candidate will work with other team members to develop/execute training programs and evaluate training effectiveness.

Essential Job Responsibilities:

• Support or lead new process or technology transfer from internal and external partners into GMP manufacturing department including documenting tech transfer progress and authoring technical reports

• Identify and evaluate criterial process parameters, assess underlying technical challenges, and define the best approaches to achieve suitable processes for cGMP manufacturing.

• Develop and provide process-related training to MFG personnel and author training reports during tech transfer.

• Develop and execute MFG new employee GMP technical training program in alignment with techniques of upcoming NPI programs.

• Support manufacturing department including supporting MBR development and review, trending key process parameters across manufacturing batches.

• May perform stem cell culture and differentiation, process optimization and/or scale up to improve GMP production efficiency.

• Perform other duties as assigned.

Quantitative Dimensions:

• This role will ensure the delivery of GLP and GMP material by ensuring manufacturing systems and practices are consistent, follow AGT/MA-TC policies and procedures, regulatory requirements, guidelines, and recommendations. This role will seek out, initiate, and lead process improvements, and under direction of management, will provide all training and resources to the Manufacturing staff. This role serves as the Mfg. Technical Subject Matter Expect (SME) for Mfg. Operations.

Organizational Context:

Report directly to Director of Manufacturing Science and Technology (MS&T) or delegate.

Qualifications:

Required

• BS or BS or MS degree in biology.., bioengineering, or related scientific field with relevant experience of 4 years for BS, or 2 years for MS2OR ..4 in a biotechnology or pharmaceutical industry focusing on cell therapy development. for MS, 0-3 year for PhD in stem cell field and/or in a biotechnology or pharmaceutical industry focusing on cell therapy development

• Proficient at small to medium scale cell culture processes with solid knowledge of cell biology, drug product/substance manufacturing

• Excellent aseptic skills.

• Able to develop, revise, and review protocols or SOPs, batch records, cell culture process development and technical reports.

• Excellent written and verbal communication skills.

• Detail oriented with good organizational skills and documentation practices to maintain accurate records.

• Ability to work effectively independently, as well as part of a team in a collaborative environment with internal and external partners across multiple scientific disciplines.

• Able to manage priorities and maintain timelines for multiple projects in a fast-paced setting.

Preferred

• Knowledge and direct experience with various human cell culture platforms, especially in human pluripotent stem cell culture and differentiation processes towards products for regenerative medicine

• Experience with molecular- and/or cell-based assays such as RT-qPCR, Flow cytometry a plus.

• Knowledge and direct experience in technical transfer and/or GMP manufacturing process and good documentation practices a plus.

• Proficiency using Microsoft Office software (Excel, PowerPoint, Word).

• Strong attention to details supported by excellent time management and organizational skills.

• Experience in leading classroom and OJT trainings of GMP personnel.

• Experience with Quality Systems, RCAs, and investigational ownership.

• Able to work flexible hours including working in weekends.

Working Conditions

• This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, regular reaching over head activities, and independent mobility to lift up to 25lbs.

• This is an on-site role working in a cGMP regulated manufacturing facility.

• On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities (0-5%)

Benefits:

• 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

Benefits:

• 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

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Category Massachusetts TC

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans