Job Information
WuXi Biologics Assoc. Dir., Manufacturing Training in Worcester, Massachusetts
Summary Reporting to the Head of Operations MFG11, the Training lead will play a key role in planning, management, and implementation of compliance-related and technical training within the Manufacturing group. This role will act as a key point of contact with the Operations Department Training team ensuring accuracy and compliance of Manufacturing training KPIs, training curricula, and records. During our start-up phase, this role will be crucial in overseeing and ensuring continuous improvement in the training of new Manufacturing staff in Bioprocess associate roles. Qualifications \ BSc or MSc in Chemical Engineering, Bioscience, or Biotechnology. A masters level qualification would be advantageous. \ More than 8 years in biopharmaceutical manufacturing, ideally with experience in both upstream and downstream processing. \ Experience in dealing with FDA, and/or EMA and CFDA, and have a solid understanding of quality systems in terms of deviation, investigation, CAPA, and change control. \ Experienced technical trainer. \ A proficiency in operating a drug substance commercial manufacturing facility and/or a pilot plant. \ The individual needs to have a good understanding of DQ, FAT, SAT, IQ, OQ, & PQ (commissioning and qualification \ Experience with GMP systems such as SAP, Orchestrate, benchtop equipment, etc. \ A proficiency in operating a drug substance commercial manufacturing facility and/or a pilot plant. \ The individual needs to have a good understanding of DQ, FAT, SAT, IQ, OQ, & PQ (commissioning and qualification). An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability \ 5 PTO, 5 Sick, 2 Floating Holiday, 10 Paid Holidays \ Benefits begin your first day of employment \ Health - Cigna \ Dental - Delta Dental \ Life Mart - Employee discounts through ADP \ 401k Retirement Investment Plan Traditional or Roth - Wuxi Biologics USA LLC matches 100% of the first 2% of employee contribution and 50% match on the next 4% employee contribution. Vesting schedule for the company match is 50% after 1 year of employment and 100% after 2 years of employment. To help you save for your future, Wuxi automatically enroll employees at 6% (You have 30 days to opt out of auto enrollment) Click Here To Read Full Job Description