Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI. 

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

   

This position is responsible for all aspects of the QC laboratory operations that provide analytical services support for internal and external customers. This encompasses the entire product development lifecycle from early-stage formulation development through commercialization.

Adhering to PCI’s Values and Behaviors, the Director is responsible for strategic planning, decision-making, prioritization, customer escalations and providing a safe work environment for all laboratory personnel to meet the business, quality and customer needs.

Essential Duties and Responsibilities:

Provide Quality Control, Analytical Development and Microbiology oversight of all cGMP testing of raw materials, in-process, product release, and stability testing, clean utility and environmental monitoring testing.  Maintain a state of compliance including review/approval/tracking of all laboratory-related items (Deviations, OOS/OOT, Investigations, CAPAs, Change Controls, Training, etc.) Establish good working relationships with clients and serve as the single point of contact for any laboratory-related escalations. Meet the financial expectations of the business including monthly revenue targets, forecasts, capital requests, etc.Facilitate continuous improvement initiatives to proactively identify opportunities to improve quality and efficiency with manufacturing and development personnel. Seek regular feedback from internal and external stakeholders on improvement areas.Work collaboratively with department stakeholders (e.g. Formulation, Manufacturing, Quality, etc.) to meet project deliverables.

Ensure department personnel are provided with a safe working environment and receive feedback on their performance and career development via the quarterly management review process. Coach, lead, and mentor direct reports and build a strong team.

Assure all laboratory activities comply with the appropriate GMP and Regulatory requirements for the product and region. Assist in the development and implementation of appropriate policies and procedures to ensure the integrity of all data generated in the laboratory.

Participate and provide appropriate direction for all Regulatory and Client audits.

Other tasks as assigned by management

Work Environment:

Interacts with all departmental staff and other departments at all levels Must be comfortable presenting technical and complex issues clearly to all levels of management as well as client representativesMust be able to move between building locations on the campusMust be able to remain in a stationary position 50% of the time

Qualifications:

BS in Chemistry, Biochemistry, Microbiology, Biology or related life sciences field. Advanced level degree preferred

15+ years Pharmaceutical or Biotechnology industry experience 

Prior experience in leading a commercial, aseptic drug product quality control team is highly preferred

5+ years previous Laboratory management experience

Working knowledge of Pharmaceutical GMP requirements

Prior experience in a CDMO or dealing with CDMOs preferred

Demonstrates excellent verbal, written, and interpersonal communication skills

Demonstrated ability to perform in a fast-paced environment

Ability to make decisions with incomplete/evolving information

Highly developed leadership capabilities to motivate and inspire teams

Independently motivated, detail oriented and good problem solving ability.

Demonstrates a strong customer service orientation with effective follow through

Driven to excellence while encouraging others to engage in process improvement and innovation

A leader who inspires and motivates, through excellent listening skills and a willingness to mentor team members

Management of 5+ direct reports across multiple sites with overall group greater than 40 people    

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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.