Senior QC Specialist I, Cell Therapy QC Microbiology Testing

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?

Join us as aSenior QC Specialist I, Cell Therapy QC Microbiology for our Testing group in our Lexington, MA office.

Primary Duties

Initially (2021-2022), support the build-out, commissioning and preparation of the laboratory, equipment, documentation and training associated with the methods to be transferred to the new Cell Therapy facility at the Massachusetts Biologics Operations (MA Bio Ops) Lexington site from the Cambridge Facility. Focus on method transfer of sterility and endotoxin testing. Participate in the building of LIMS/MODA architecture to support QC and EM testing.

Thereafter, responsible for testing in the QC Microbiology and Sterility laboratories in the new Cell Therapy facility. This includes but is not limited to testing according to both cGMP requirements and supply chain needs, ensuring tests are executed in accordance with written procedures, training is completed, and test performance and data trending are performed regularly and promptly reviewed.

Flexibility to learn and support the QC Analytical area on techniques such as Immunophenotyping, RT-PCR, and Cell-Based potency assay.

Demonstrated ability to work autonomously as well as within a cross-trained team environment. Must have the ability to coach and influence junior analysts.

Expected to plan and execute special projects with minimal direct supervision to support the QC function. Drive thorough Microbiology-oriented investigations to completion.

Collaborate closely with other individuals and teams across the site in fulfillment of both department as well as site objectives, including colleagues and counterparts across other areas within QC, QA, Manufacturing, Operations and Supply Chain Management. As needed, interface with members from Regulatory Affairs, Human Resources, as well as other key support functions.

Responsibilities

Percentage of Time:

• 60% of Time: Operations management (e.g., testing, laboratory, SOPs, compliance, metrics)
• 25% of Time: Technical SME (e.g., troubleshooting, investigations)
• 10% of Time: Program management (e.g., new product introductions, methods transfers)
• 5% of Time: Continuous improvement (e.g., efficiency gains, LEAN and grassroots initiatives)

Education and Experience Requirements

Education:

• Minimum Bachelor's degree in a biological science or related discipline

Experience:

• Minimum of 6 years of Quality Control experience or related field in the biotechnology or pharmaceutical industry
• Experience with Cell/Gene Therapy preferred
• Experience with laboratory/facility design and subsequent construction/commissioning preferred but not required
• Strong working knowledge of microbiological methodologies including environmental/facility monitoring, sterility, BACT Alert and endotoxin preferred
• Thorough understanding of cGMP regulations, Quality Control expectations and requirements, and industry best practices
• Experience with interacting and collaborating with cross-functional team
• Experience with method validation and technology transfers preferred
• Experience with equipment qualifications and analytical instrument/software validations preferred

Key Skills, Abilities, and Competencies

• Ability to make informed, data-driven, difficult, robust, rationalized and timely decisions
• Good interpersonal skills including ability to enable trust, build authentic relationships, constructively challenge conventional thinking, influence stakeholders, lead and cooperate in a team setting, share information and deliver results
• Effective verbal and written communication skills
• Exemplify the Takeda Values: Integrity, Fairness, Honesty & Perseverance
• Organizational agility (knowledgeable about how an organization works) and ability to apply that capability to lead change, deliver strong results and build the confidence as well as trust of stakeholders

Complexity and Problem Solving

• Responsible for effectively managing QC testing schedules and strategies for GMP raw material, in-process, release and stability samples
• Provides Tier 1 input to the Cell Therapy QC Microbiology Associate Director to make informed and timely decisions regarding laboratory issues and overall QC test performance, monitoring and trending

Internal and External Contacts

Key Internal Stakeholders (including but not limited to):

Biologics Operations Unit Quality, MA Bio Ops Site Quality, Site Operations Leadership Teams, Manufacturing, Technical Services, Facilities & Engineering, External Quality, Quality Supply and Distribution, Supply Chain, Quality Assurance, Operational Excellence, IT, Pharmacovigilance, Regulatory Affairs

External:

Health Authorities (e.g., FDA, EMA, MHRA, PMDA, TGA, ANVISA)

Other Job Requirements

• Campus travel between buildings at Lexington site is expected to be frequent to support interaction with peers across the site
• Ability to wear clean room garments, stand for up to 4 hours, and lift 30 lbs.
• Site-to-site travel between MA locations (Lexington, Cambridge, Alewife, North Reading) is expected to be occasional
• Flexibility to support Cell Therapy operations outside of regular business hours on occasion.
• Geographic travel (domestic and international) is expected to be minimal

This job posting excludes CO applicants

Locations

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time