This is a full-time exempt position that supervises a cross-functional team coordinating the transfer of products from R&D to manufacturing. Responsible for evaluating, coordinating, and managing all activities related to the transfer of products from R&D (Biochemistry) to BFDF BioChem and BFDF BioReagents, as well as transfer of products ^TO or FROM external partners. This includes, but is not limited to, writing manufacturing documentation, writing/executing verifications, coordinating data collection and analysis, coordinating efforts of multiple departments to establish new product requirements, and specifications, and move the product to full launch. Additionally, the Industrialization Manager will be responsible for supervising technical writers and transfer coordinators. May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel.
Principal Job Duties and Responsibilities:
- Responsible for managerial duties related to technical writers and product transfer coordinators. Reviews and approves time clock, participates in employee reviews, training, etc.
- Uses project and program management techniques to assign all work and product transfers to the appropriate parties.
- Perform all work in compliance with company policy and within the guidelines of BFDF’s Quality System.
- Expert knowledge of principles and concepts of product transfer.
- Maintains system to track open projects and track, maintain the associated timelines.
- Review project risks, identify issues, work with engineers, scientists, and manufacturing to make sure quality is being met.
- Review staffing and make requests for hires as needed.
- Revise transfer procedures as necessary to streamline efforts and maintain quality.
- Help generate TCOs, rework plans, NCRs as needed and requested to ensure timely release of products under the Quality System.
- Organize and facilitate meetings to propose/review product questions and issues.
- Revise, draft, and post documents using the Quality System.
- Identify project issues, and work with the teams to use resources wisely.
- Supervise all Transfer Specialists, Product Labeling and Documentation specialists and/or Technical Writers.
- Works closely with Scientists, Engineers and Program Mangers to effectively move products into manufacturing.
- Works with team members to put in place documentation (WIDs, Batch Records, BOMs, QC specs) required for product transfer.
- Demonstrates technical proficiency, project management knowledge, ability to collaborate well with others, and independent thought.
- Works closely with Program Mangers to develop product launch plans, timelines, and resource allocations.
- Identifies issues that may impact product launch and recommends appropriate action.
- Works closely with Administration on cost proposals pertaining to product transfer.
- Interfaces with Quality Department and Sales and Marketing during the transfer process is required.
Training and Education
- Requires a B.S. in a biological science discipline or evidence of equivalent experience.
- At least 5-7 years in industry with direct experience pertaining to product development and manufacture.
- Proficient in Microsoft Office program suite
- Strong documentation practices, organizational skills, and attention to detail
- Strong verbal and written communication skills
- Excellent interpersonal skills
- Ability to elicit cooperation from a wide variety of sources, including many departments within the company and work as a team player
- Ability to effectively prioritize and execute tasks in fast-paced environment
- Ability to problem solve
- Must be able to work at a computer.
Desired, but Not Required Skills:
- Statistical and analytical skills
- Familiarity with following software packages: Visio, MS Project, MS Office suite
- Familiarity with project management knowledge and skills
- Project Management certification (i.e., PMP or other)
Benefits and Compensation:
- We offer competitive salaries
- Vacation/holiday pay
- Medical benefits
- Stimulating work environment