Tech Ops Manager - Biopharma CDMO - Massachusetts

Burlington Permanent USD110,000 - USD145,000
  • Process development for early phase drugs through small scale commercialization
  • Standardize + implement effective tech transfer practices internally/externally

About Our Client

Our client provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. They are unique in their focus of providing process development for early phase drugs through small scale commercialization. As such their development personnel require an understanding of process development from both a scientific and engineering perspective. Candidates with either background can be successful and will be considered.

Job Description

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Description

  • Lead the Technical Operations team to include daily oversight, development of weekly/monthly goals and schedules activities.
  • Participate in all phases of production planning, tech transfer and implementation in collaboration with internal supporting departments.
  • Responsible for the technical transfer/new product introduction between the Engineering and Manufacturing teams.
  • Liaison with internal groups (QA, QC, Regulatory, etc.) to facilitate issue resolution.
  • Ensure unit's compliance with GMP and all of its related elements such as documentation (SOP's and validation protocols, etc.).
  • Completes annual performance appraisal for direct reports.
  • Coaches and develops junior staff. Works with site leadership to ensure talent is recognized, rewarded and retained.
  • At times, operate as an SME for GMP investigations (e.g. CAPA, departures, CCRs) as well as finalize closure reports for departures which are assigned to Technical Operations.
  • Direct client interaction, summarizing Technical Operations-related work completed verbally as well as written. Provide oversight and support to the Technical Operations team in order to facilitate effective client interaction.
  • Track department deliverables and trend performance against metrics.
  • Promote a collaborative team environment that focuses creativity, innovation and high performance.
  • Key participant in driving improvements through customer delivery and improved quality, as well as cost reduction/avoidance to drive growth and improve profitability.
  • Develop new manufacturing and aseptic filling processes to meet client requirements. Ability to troubleshoot, amend and accommodate the process of aseptic formulation and fill of drug product such that it harmonizes with Manufacturing Facility while protecting the integrity of client technology / product.
  • Participates in self-development activities and training
  • Will review and approve documents as "Action Owner Management" or "Area Management."

The Successful Applicant

  • B.S. in Biology, Engineering, or related.
  • 5-8 years' experience in a cGMP/FDA regulated environment.
  • U.S. employees must be fully vaccinated.
  • Aseptic technique, familiarity with clean room personnel flows is desirable.
  • Knowledge of process flows - e.g. Disposables strategies, filtration, mixing strategies, fluid transfer to and from various vessels/biobags.
  • Working knowledge of engineering processing aids such as sanitary connections, valves and pharmaceutical process design. Experience with CIP/SIP a plus.
  • Computer literate with good working knowledge of spreadsheet software (Visio or equivalent drawing programs a plus).
  • Experience with particle size reduction techniques, such as extrusion, microfluidization, or homogenization.
  • Experience with lyophilization principles.
  • Familiarity and understanding of cGMP's in a accordance with 21CFR210, and 21CFR211.
  • Knowledge and understanding of the principles associated with aseptic filling technology (e.g. rotary piston/positive displacement pump, peristaltic pump systems).
  • Experienced in practicing Quality Risk Management per ICH Q9.
  • Ability to work with minimal amount of supervision; interact well with clientele as well as interdepartmentally.
  • Meticulous and highly organized.

What's on Offer

  • Join a talented workforce, where a commitment to excellence and a customer focused attitude is everything.
  • Work to improve patients' lives with the pharmaceuticals you develop and manufacture.
  • Great size: Small enough to remain agile and nimble, empowering you to make your mark in discernable ways as our organization evolves. Yet large enough to provide your work with the potential for global reach and impact.
  • Events that help teams to bond and become even better collaborators: After-hours get-togethers, lunch-and-learns, holiday parties, birthday celebrations and special themed events designed to brighten the workday.
  • Comprehensive total compensation package that aligns directly with business & individual results.
  • Benefits and perks designed to provide support, including health and wellness resources, insurance options, financial resources, and advantages for work, life and family.
Contact
Faith Emery
Quote job ref
JN-012022-4578497

Job summary

Sector
Life Sciences
Sub Sector
Biotechnology
Industry
Healthcare / Pharmaceutical
Location
Burlington
Contract Type
Permanent
Consultant name
Faith Emery
Job Reference
JN-012022-4578497