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Technical Team Leader, Gene Therapy Production

Employer
Pfizer
Location
Andover, Massachusetts
Salary
Competitive
Closing date
Nov 29, 2020

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Discipline
Physical Sciences, Information Technology, Other, Manufacturing/QA/QC
Position Type
Full Time
Organization Type
Pharma
ROLE SUMMARY
  • The primary purpose of this role is to create break-though therapies that will change patients' lives.
  • The Andover Gene Therapy Plasmids manufacturing Team is seeking a highly motivated and experienced individual for the position of Technical Team Leader.
  • In depth experience and knowledge of current state of the art biological manufacturing processes and associated equipment is a must. Prior experience working in a technical leadership role in a large-scale microbial manufacturing capacity highly preferred.
  • The manager will be closely involved in the startup of a cutting-edge Gene Therapy Facility that will require commissioning, validation (IQ, OQ, PQ), engineering runs and initiation of cGMP production in year one of operation.
  • This position involves operating closely in an interactive and collaborative environment with stakeholders across multiple functions including QA, QC, Operations, Engineering and Supply Chain.
  • Have a demonstrated track record of leveraging collaboration across groups and resolving competing priorities to achieve results.
  • Have experience dealing with large technical groups of engineers, scientists and technicians in a large-scale multi-product biotech facility.
  • Have experience troubleshooting and resolving processing ang highly technical issues.
  • Operate with a high degree of independence and self-directed interaction and collaboration with multiple groups both on site and off site to achieve project goals. Skills in matrix management and "influencing without authority" are critical.
  • Lead cross-functionalteams in the evaluation and implementation of solutions that increase process robustness and/or yield.
  • Be a champion for the dissemination of Andover experiences across the network and to the larger Biotech audience outside the company through presentations at appropriate internal and external venues and conferences.


ROLE RESPONSIBILITIES
  • Responsibilities include the management of a cutting-edge Gene Therapy Plasmid manufacturing process in a multi-product cGMP facility capable of manufacturing commercial, clinical and development stage biologic products.
  • The Technical Team Leader is responsible for management of a group whose primary focus is supporting the manufacturing process, technical assessment of processes including technology transfer, maintaining a culture of compliance, innovation, and fostering continuous improvement within their Asset Team.
  • The manager will need to guide their team of approximately 4-6 scientists/engineers with process and technical knowledge and to lead troubleshooting activities, provide investigations support, implement change controls, analyze process data, and identify and implement process improvements and to nurture a culture of continuous improvement
  • Knowledgeable in operations processes including solution preparation, fermentation, or purification. Knowledgeable/experienced with DMAIC processes, investigation processes, and automation a plus.
  • Strong understanding of industry knowledge (GMP regulations applicable) and an understanding of business operations.
  • Actively shares knowledge with others across assets through existing knowledge sharing processes/systems.
  • Across manufacturing assets, identifies and makes improvements to existing work processes/products. Learns to take appropriate risks and applies ingenuity
  • Solves more complex problems within area of expertise or cross-functional teams outside immediate area of expertise
  • Supports developmental and training opportunities for direct reports. Depth analysis on resource / skill balance to drive/advocate for changes either within or between teams.
  • Responsible for coaching/mentoring both technical and non-technical staff.
  • Encourages the participation and perspectives of all team members. Effectively listens to and explains difficult issues to reach shared understanding and building alignment. Builds alignment across manufacturing assets. Interacts with the Engineering, Quality, Technical Services, and Operational Management departments.
  • Guide people in their group with process and technical knowledge to lead troubleshooting activities, provide investigations support, analyze process data, and identify and implement process improvements and a culture of continuous improvement.
  • Decision making autonomy when limited impact outside of direct team. Decision escalated when impact has significant impact on department.
  • Demonstrates effective written and oral communication skills. Ensures timely flow of information to appropriate individuals.


BASICQUALIFICATIONS
  • BS/BA in Science, Engineering or related field with 10+ years of relevant experience required OR MS in Science, Engineering or related field with 7+ years of relevant experience required.
  • Extensive experience in biopharmaceutical processes in such area as upstream and downstream large-scale manufacturing required. Extensive exposure to and understanding of associated processes and functions involved in the manufacture of complex biologics, including Quality systems and process engineering.
  • Prior leadership experience (direct or indirect) required.


PREFERRED QUALIFICATION
  • Previous experience in a cGMP environment.
  • Previous management experience a plus.


PHYSICAL/MENTAL REQUIREMENTS
  • Must be able to climb flights of stairs and be standing for ~1-2 hours at a time and be able to lift 40 lbs.
  • Inspiring - Motivate and develop self and others to drive the business forward
  • Courage - Consistently demonstrate accountability and integrity
  • Resilience - Respond to change with agility, optimism and innovation
  • Decisive - Manage complexity to make timely informed decisions
  • Focus - Develop impactful short and long-term solutions for our customers and patients
  • Connected - collaborate with others to accomplish shared goals


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • This role is primarily 1st shift, Monday - Friday.
  • Occasional off-shift requirements may be required.


Additional Job Details:
  • Last Date to Apply for Job: December 13, 2020
  • Referral Bonus Eligible
  • #LI-PFE


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EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Manufacturing

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