Laboratory Manager

Include the following but other duties may be assigned:

• Manage the Formulation, Purification and Filling teams in an registered ISO 13485 site that builds “make to order” and “make to stock” Enzyme, Oligo and Buffer products.
• Enzyme purification process oversight, technique implementation, and process validation support
• Supervise, mentor and foster the professional development of the staff in the area of responsibility.
• Be responsible for the production areas; that they are maintained and used in accordance with safety protocols and that the staff is trained and enabled to work safely
• Ensure that operational capacity for the group is maintained to meet the production forecast.
• Ensure that laboratory personnel are trained and effectively utilized to perform their job functions efficiently, effectively, and in accordance with documented procedures.
• Responsible for daily oversight of batch record review and production order variance review, assuring correct materials are issued and inventories are accurate.
• Coordinate activities cross-functionally with internal planning, production and QC teams.
• Review and write SOPs as necessary.
• Assist with managing investigations for product/process nonconformities.
• Assist with managing validations and implement cost-reduction and/or process efficiency improvements.
• Participate in the product-transfer processes.
• Report team metrics and performance measurements for the group, team and individuals.

Education and Work Experience (minimum education level and years of experience required to meet the expectations of the position):

• Must have a BS/BA degree in a scientific or engineering discipline
• 2-5 years’ experience in supervising operations (liquid handling) or equivalent
• At least 2 years of prior supervisory experience in a manufacturing environment (must have led direct reports)
• Enzyme
  
  Experience:
  
  Optimize enzyme production (fermentation and purification) processes, primarily focused on purification process, for improved yield, quality, and efficiency. Tech transfer of new enzyme production process. Experience in downstream processing, including, IEX, HIC, Affinity, TFF and other chromatography skills. Strong knowledge and hands‑on experience in nucleotide‑related enzymes and process scale‑up are highly desirable. Experience with production strain improvement, genetic recombination, and fermentation process is desirable.
• ISO and GMP experience preferred
• Ability to use general lab equipment

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Technical Expertise:
  Must have a robust understanding of the scientific principles and techniques relevant to the laboratory areas of focus ex. Cell fermentation and purification techniques
• Management skills:
  Ability to manage staff, resources and projects effectively
• Communication skills:
  Able to communicate effectively with staff
• Attention to detail:
  Focus on careful attention as it relates to production, data analysis, and documentation processes
• Organizational
  
  Skills:
  
  Ability to organize and prioritize tasks effectively
• Problem Solving:
  Ability to solve practical problems

• Intermediate to advanced skills with Microsoft Windows and Office products, including Word, Excel, Access, and PowerPoint.

• Command of the spoken and written English language is required.
• Must be able to communicate effectively with employees at all levels of the organization in writing, on the telephone and in person.

• Must be able to exercise excellent independent judgment for decision‑making responsibilities.
• Must also be able to prioritize departmental responsibilities in a multi‑tasking environment. Impact of errors is very high, and may result in production delays, backorder, regulatory citations and/or product recall.

• The work environment is fast‑paced and involves the ability to quickly change priorities and multi‑task while maintaining a professional demeanor.
• The position requires work with potentially biohazardous and/or chemically hazardous materials and the ability to lift and carry 25 lbs.
• Must be able to sit for extended periods of time