Job Summary

Join our busy and growing company - dynamic job with opportunity for growth. We are seeking highly flexible individual with a strong clinical laboratory background and management skills to train and build our Raw Materials, Lab Services, Finished Goods and Method Development laboratory teams.

This outgoing individual will provide leadership to and coordinate the company testing, assay validation and R&D support functions. This position reports to and works closely with the Sr. Director of Quality.

Primary Duties and Responsibilities

1. Maintain a safe, efficient, functional and compliant laboratory operational environment developed to the required standards in accordance with corporate guidelines
2. Provide microbiological and chemical expertise and support for training, product investigations, deviations, CAPA, quality and operational improvements, etc. to ensure continued compliance with regulations
3. Oversee daily operations of QC laboratory including incoming raw materials testing, screening and release of milk donations, in-process product testing, final container testing, and utilities/environmental monitoring.
4. Coordinate activities with Planning, Manufacturing and Quality Assurance to ensure production schedules are met.
5. Oversee investigations related to the laboratory including OOS and nonconformance investigations
6. Streamline and standardize various laboratory processes to improve efficiency, accuracy and responsiveness.
7. Oversee development, validation and implementation of new assays and transfer of assays from R&D.
8. Assist in identification and qualification of outside testing laboratories and raw material vendors
9. Develop short and long term plans to support Prolacta’s Strategic Imperatives, including staffing, infrastructure and equipment plans
10. Partner with Manufacturing to meet production targets and goals

Job Requirements and Qualifications

1. Master's Degree or Ph.D. – chemistry, biochemistry or biological science

2. Minimum 12 years’ experience, 7 years in a leadership or supervisory role (preferably in in pharmaceuticals or biologics)

Other Knowledge, Skills and Abilities

1. Detailed knowledge of quality fundamentals, quality control, and quality management systems, including laboratory investigational tools

2. Familiar with CLIA laboratory requirements for Licensed Diagnostic Testing is a plus

3. Experience with presenting information to the Regulatory Authorities

4. Experience with Operational Excellence in fast moving laboratory and/or manufacturing environment

5. Experience with project management and statistical analysis

6. Ability to manage the use including changes/upgrades to LIMS (laboratory information management systems)

7. Skills in personal computer operation with appropriate work process, database, project management and spreadsheet software (e.g. Microsoft Office)

8. Demonstrated ability and flexibility in a 7 day/multi-shift operation

9. Strategic planning experience

10. Able to create and manage budgets, including capital planning and long-term strategic planning

11. Ability to work without supervision

12. Effectively interview and select candidates

13. Handle conflict management and bring resolution

14. Effective relationship building skills

15. Ability to produce and present clear, concise and professionally written communications and presentations

16. Performance Management, effective coaching and directing of others

17. Positive attitude and motivation

18. Ability to operate in a complex matrix environment

19. Visionary and forward-thinking

20. High level of business acumen

21. Strong PC skills, MS Outlook, Word, etc.

22. Must be able to work under pressure, meet deadlines, and be flexible when working on multiple projects simultaneously

23. Strong Critical thinking and decision making skills

24. Strong business ethics

25. Scorecard Management

Work Environment (Location, travel, shift, on-call, etc.)

Location

City of Industry, CA and Duarte, CA

Travel

On occasion

Physical Requirements

a. Activities. How much on-the-job time is spent in the following physical activities? Show the amount of time by checking the appropriate boxes below.

Amount of Time
Activity	None	Up to 1/3	1/3 to 2/3	2/3 or more
Stand		X
Walk		X
Sit				X
Talk or hear				X
Use hands to finger, handle or feel		X
Climb or balance	X
Stoop, Kneel, crouch or crawl	X
Reach with hands and arms	X
Taste or smell	X

b. Lifting. Does this job require that weight be lifted or force be exerted? If so, how much and how often? Check the appropriate boxes below.

Amount of Time
Activity	None	Up to 1/3	1/3 to 2/3	2/3 or more
Up to 10 pounds		X
Up to 25 pounds	X
Up to 50 pounds	X
Up to 100 pounds	X
More than 100 pounds	X

Direct Reports

Sr. QC Manager

LIMS Administrator

Method Development Principle Analyst

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

“Prolacta Bioscience, Inc. is an Equal Employment Opportunity Employer.” Prolacta Bioscience, Inc. is committed to a proactive program of affirmative action and diversity development. The Company will continue to recruit, hire, train, and promote into all job levels without regard to race, religion, gender, marital status, familial status, national origin, age, mental or physical disability, sexual orientation, gender identity, source of income, or veteran status.