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Associate Director of Manufacturing / Evening shift

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. 2018-31491
Salary Range: NA
Minimum Qualification
8 - 10 years

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