Manufacturing Group Leader

Location: Bedford, MA

Position Scope:

The Group Leader coordinates routine activities associated with either the Aseptic or Cross-link Manufacturing Process.  Working with the Manufacturing Supervisor and/or Manager, the Group Leader ensures that all routine processes are carried out under strict adherence to current SOPs, cGMP regulations and production schedules.

Strategic Focus Areas:

  • Perform all activities within the confines of the Quality System and cGMP principles
  • Participate in projects and activities which support the growth efforts of the Company
  • Maintain cost discipline within assigned programs

Specific Tactical Responsibilities:

  • Oversee and perform routine aspects of the Manufacturing Process, including but not limited to the:
    • Setup of all manufacturing unit operations, primarily all CIP, COP, FIT, SIP and SOOP operations
    • Production of raw material intermediates
    • Production of bulk concentrate
    • Formulation of bulk concentrate
    • Filling of formulated bulk 
    • Submission of in-process and final samples to Quality Control
    • Accountability of all materials and products
  • Report employee performance issues and process issues to Manufacturing Management
  • Act as a key contact during audits and inspections
  • Act as the subject matter expert in the area in which the lead position is designated
  • Plan with Manufacturing Supervisor and Manufacturing Manager to ensure the on-time delivery of quality products per established cost standards
  • Perform routine inventory checks to ensure materials and consumables necessary to perform production activities are available and/or on-order when the need-by date
  • Perform quarterly physical inventory checks with Materials Management to ensure financial accountability of all material
  • Maintain and ensure accuracy of all manufacturing records, documents and logbooks
  • Provides training and guidance to employees according to established policies and cGMP guidelines
  • Write and revise standard operating procedures and batch records based on routine operations
  • Maintain manufacturing suite environment to comply with regulatory requirements
  • Execute daily activities as prioritized by Manufacturing’s goals of quality, delivery and cost while promoting mastery, autonomy and purpose throughout the Manufacturing staff  
  •  Responsible for other duties and projects as assigned

Job Complexity:

The Group Leader works on assignments that are routine or semi-routine in nature where ability to recognize deviation from accepted practice is required.  The position works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations. The Group Leader normally receives no instruction on routine work, general instructions on new assignments. 

Supervisory Responsibilities:

None

Required Qualifications:

  • Bachelor’s degree in Chemistry, Chemical Engineering or related life sciences or relevant experience.
  • Detailed knowledge of manufacturing operations and familiarity with regulatory requirements and SOPs
  • Good oral and written communication skills

Desired Experience, Knowledge, and Skills:

  • Prior supervisory experience in a routine manufacturing position
  • Strong computer skills including word processing and spreadsheet software
  • Previous experience with MRP/ERP systems
  • Ability to work autonomously, effectively manage time and deliver results on time 
  • Excellent presentation skills, both written and in platform presentation format
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We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.

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