Massachusetts Jobs

Senior Validation Specialist, Quality Assurance

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 Senior Validation Specialist, Quality Assurance opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

The Validation Specialist, Quality Assurance, will provide QA oversight of commissioning, qualification and validation support to M-TC’s cGMP Cell Therapy Manufacturing facility as the products move through clinical trials and commercialization. This position is responsible for scientifically sound, documented evidence that our systems and processes will perform as required to standards set forth by Quality Assurance, internal clients and global regulatory bodies. The Validation Specialist will ensure that all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters and global regulatory guidelines. The successful candidate will foster compliance across a broad range of Quality Assurance areas and will work closely with counterparts in the Manufacturing, Quality Control, and Materials Management teams to help ensure high quality standards and value delivery for our patients.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Individual Contributor responsible to execute QA Validation Strategy for clinical and pre-commercial cell and gene therapy manufacturing facility.

• Responsible for equipment and facility validation. Validation work may also include the following areas based on experience:

• Process Validation/PPQ

• Aseptic Process Simulation Validation

• Analytical Equipment Qualification/Validation

• Analytical Method Validation

• Authors and/or approves technical documents such as validation protocols, reports, user requirements statements, deviations and risk assessments etc. Writes, executes and approves validation protocols and reports following good documentation practices.

• Interface with system owners, IT and facilities engineering to ensure all user and compliance requirements are tested as well as support the creation of the requirements for new equipment or products.

• Evaluate vendor qualification packages and create supplemental protocols as necessary.

• SME for validation software, such as Ellab ValSuite dataloggers to perform mapping studies.

• Maintains close contact with manufacturing, facilities, and laboratory departments to assure effective communication on issues related to validation and the validated state of equipment and endures effective communication on validation issues.

• Performs periodic review of equipment and systems.

• Develops testing strategies and rationale for equipment/systems.

• Collaborates with cross-functional stakeholders regarding quality events (e.g., deviations, Corrective / Preventative Actions (CAPAs), etc.), assisting in investigations and ensuring quality records are clearly written, technically sound, and provide thorough root cause analysis and risk assessment.

• Serves as a resource fluent in Global Validation Strategy for the organization, ensuring all steps of the GMP organization remain compliant with Astellas procedures and domestic / international GMP regulations.

• Develops compliant validation processes and procedures to satisfy existing and new compliance requirements and leads improvement of existing work practices.

Qualifications:

Required:

• BS/BA, or equivalent, in Life Sciences, Engineering, or Chemistry with 3-5+ years of related validation experience within GMP-regulated industry, or 5+ years with Masters degree. In lieu of a Life Sciences, or equivalent, degree, consideration will be given to candidates with minimum of 10+ years of industry experience in biotechnological and/or pharmaceutical quality, manufacturing, or other industry requiring high technical aptitude and attention to detail.

• Experience supporting biologics, cell therapy and/or gene therapy.

• Demonstrated knowledge of cGMPs for biotechnology. Working understanding of ICH Q7, Q8, Q9, Q10, and other international regulatory requirements.

• Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions, and exercise sound Quality-by-Design principles. Experience presenting these outcomes to management.

• Fluency in Deviation investigation techniques, root cause analysis methods, CAPA effectiveness verification, and product impact assessments.

• Working fluency in the Microsoft Office productivity suite (including Excel to include basic formulas, and creation / formatting of charts and data tables and PowerPoint).

• Comfort presenting data, facilitating meetings with senior stakeholders, and maintaining minutes of key decisions and outcomes.

• Solid technical writing skills and ability to document work a meticulous, accurate and timely manner. Solid written and oral communication skills and ability to work interdepartmentally with some basic supervision in an effective manner to carry out daily duties.

• Experience in an environment subject to regulatory audits.

Preferred:

• Specialized knowledge of industry-related niche topics: bar coding, cell culture, auditing techniques, QC methods, HEPA filtration science, etc.

• Previous experience interacting with regulatory agencies, representing technical deliverables as a subject matter expert, audit hosting / support, etc.

• Experience with Contract Manufacturing Organization (CMO) oversight and compliance considerations.

• ASQ certifications (e.g., certified quality engineer, quality auditor, quality professional, etc.)

• Experience with an electronic document management system

Work Environment:

• This position is based in Westborough, MA and will require on-site work.

• This position will require working frequently in a cleanroom environment.

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

Compensation: $87,800 – 117,000 (NOTE: Final salary could be more or less, commensurate with experience)

#LI-LK

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

Category BioPharma QA

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

EOE including Disability/Protected Veterans