Lead Manufacturing Technician

Location: Bedford, MA

Position Scope:

The Lead Crosslink Manufacturing Technician is a subject matter expert who leads and delivers excellence in manufacturing processing.  This individual is a role model with safety, Standard Operating Procedures (SOPs) and cGMP and is the primary technical resource for troubleshooting and cross functional projects.

 Specific Tactical Responsibilities:

  • Implements best practices for manufacturing; is primary contact for troubleshooting and issue resolution or escalation
  • Provides technical support working with cross functional teams and executes transfer of process changes/improvements for floor operations
  • Creates and follow-up on work orders
  • Communicates/coordinates scheduling and staffing plan
  • Oversees and executes of all routine and critical operations as well as   commissioning and validation activities
  • Ensures documentation is complete, reviewed and meets good documentation practices (Forms, Logbooks, OPMs, Batch Records, etc.)
  • Initiates deviations or investigations and works with cross functional departments to identify root cause
  • Implements corrective actions and action items for GMP investigations and CAPAs
  • Responsible for floor inventory and communicating production schedule changes
  • Monitors material consumption and coordinate all materials deliveries
  • Performs required real time ERP transactions affiliated with material receipt or consumption
  • Recommends and implements process changes/improvements or safety/ergonomic improvements
  • Ensures work is carried out in a safe manner, notifying management of safety issues and risks
  • Acts as subject matter expert for all critical processes within department by performing critical steps when needed and performing full skill development training to junior staff.
  • Assists with identifying training needs, conduct skills development training and provide feedback to supervisor or manager
  • Revises and authors Standard Operating Procedures/Batch Records/OPM’s
  • Communicates any quality issues/concerns to Supervisor and QA
  • Provide from floor metrics to Manufacturing management. (i.e. Schedule Adherence, Fill Volumes, and Fill Yields)
  • Lead on floor MDI meeting along with end of shift recap meetings with staff

Experience, Knowledge, and Skills Required:

  • Minimum 6 years’ experience in cGMP manufacturing with High School Diploma or equivalency or Bachelors’ degree in Chemistry or Chemical Engineering or relevant experience or related field or previous relevant experience
  • Ability to work flexible hours to complete work activities
  • Must possess good written and verbal communication skills
  • Must be proficient in computer skills and Microsoft Office (Word, Excel, PowerPoint, Access, etc.)
  • Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas; ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes
  • Ability to lift, pull or push equipment requiring up to 25-50 lbs; ability to stand for 6 hours in a production suite
  • Ability to perform computer based real time ERP transactions
  • Ability to climb ladders and work platforms
  • Ability to work around chemicals (alcohols, acids & bases)
  • Ability to work flexible hours to complete work activities

Desired Experience, Knowledge, and Skills:

  • Experience working in a clean room or using aseptic technique
  • Experience using and troubleshooting commercial scale automated equipment
  • Experience performing in and leading a result driven, team environment
  • Experience performing ERP transactions using SAP and maintaining spreadsheets


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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.