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Associate Director of Manufacturing/Evening shift
Job Number: 2018-31491
Category: Biotechnology
Location: Mattapan, MA
Shift: Evening
Exempt/Non-Exempt: Exempt
Business Unit: MassBiologics
Department: MassBiological Labs - MassBiologics of UMMS - W416800
Job Type: Full-Time
Salary Grade: 48
Num. Openings: 1
Post Date: Aug. 30, 2018

MassBiologics

GENERAL SUMMARY OF POSITION:

The Associate Director, Manufacturing, is responsible to manage and oversee the manufacture, assembly, and labeling of clinical and commercial biologic products. Manages the operation of manual and semi-automatic and automated production equipment. Ensures all manufacturing work complies with cGMP guidelines.

MAJOR RESPONSIBILITIES:

  • Directs the cGMP clinical and commercial manufacturing of biologic products. Ensures that product is released in a timely manner and meets all required specifications.
  • Oversees scheduling and manages set-up, sterilization, cleaning and maintenance of process equipment and manufacturing runs.
  • Proposes long term and intermediate (monthly) projected production scheduling to meet organizational manufacturing goals.
  • Conducts complex troubleshooting of procedures and equipment. Oversees root cause investigations of problematic manufacturing runs and makes recommendations to improve runs.
  • Oversees validations and performance qualifications of equipment and/or processes. Assembles and analyzes data. Collaborates with Manufacturing Compliance and Quality groups to develop strategic plans to ensure that all quality requirements are met.
  • Assists management and compliance personnel in organizing and conducting periodic training sessions, especially ones that involve the purification and compositing processes.
  • Ensures that all necessary materials and equipment are available for manufacturing runs.
  • Develops plans to ensure timely equipment repair, preventative maintenance, and facility renovations.
  • Ensures that all required documentation is complete and accurate, including but not limited to , reports, SOPs batch records and in-process forms. Writes and reviews departmental SOPs.
  • Makes recommendations for cost effective improvements to MassBiologics’ manufacturing procedures.
  • Hires, manages and trains staff. Plans and assigns duties to meet departmental and organizational objectives. Utilizes technical expertise to provides guidance and direction to staff; establishing expectations, defining roles, supporting career development and managing performance.
  • Performs additional job related duties as required.

REQUIRED QUALIFICATIONS:

  • Requires a Bachelors degree Biology or Chemistry preferred and a minimum of 8 years of relevant experience (including management experience) or equivalent
  • Prior experience with Aseptic manufacturing is required.
  • Prior experience in one or more of the following areas is preferred: cell culture / bioreactor operations; purification; fill/finish.
  • Prior experience of working successfully in a supervisory/management role required. Demonstrated success in managing staff performance. Ability to motivate staff to work effectively and hold staff accountable to individual and departmental goals
  • Ability to maintain extensive working knowledge and proficiency in applicable CFR 21 regulations and all current procedures within biologics manufacturing
  • Computer literate and proficient in MS Word, Excel and other relevant electronic systems
  • Excellent critical thinking, time management and organizational skills. Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines
  • Possesses strong attention to detail, ability to maintain accurate records and excellent proofreading skills.
  • Excellent written and verbal communication skills. Ability to communicate effectively with others internally (up, down, and laterally) and externally to the organization
  • Ability to work off shift hours as required; ability to lift up to 50 pounds using proper lifting technique.

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