Director, Biologics (Bioanalytics & QC)

The responsibilities of the Project Director include leading teams addressing complex client issues. Individuals in the role of Project Director possess a deep understanding of business and corporate strategy relating to drug research, development, submissions, approvals process and pre-approval and post-approval regulatory matters, and have an excellent overall grasp of issues relating to the pharmaceutical industry. Experience in biologics and aseptic processing is required. Having expertise in cell and gene therapy is welcome. This individual works closely with Executive Management / Management teams, including other Consultants, Principal Consultants, Managers, Directors, Vice Presidents, and Board Members to deliver quality client services and achieve excellent client satisfaction.

The Project Director is comfortable working in a client-oriented, professional services environment, and possesses at least 10 years of pharmaceutical industry regulatory experience. FDA regulatory experience is a plus.

The Project Director is skilled at leading company teams charged with completing day-to-day, project-related activities, formulating appropriate client recommendations, interacting with client representatives, and collaborating/participating in client solutions with other team members. To support his/her success, the Project Director will maintain current industry and leading practices knowledge and understanding and be able to link these to Lachman Consultants’ business goals, mission, and work processes/procedures.

The Project Director is a broad-minded, strategically oriented professional who can work independently, continuously develop him/herself and other team members through ongoing learning, performance feedback, and periodic engagement assessments.

Position Responsibilities / Requirements:

· In-depth aseptic operations experience.

· In depth Biologics experience, and preferred cell and gene therapy knowledge and expertise.

· Quality Operations / Quality Systems – implementation of QA and QC systems and processes for biologics/gene therapy products including testing and release of products.

· Understanding and prior experience supporting regulatory filing requirements for biologics and gene therapy products.

· Knowledge of FDA, EU and International regulations, EU, and US and industry best practices regarding aseptic operations and applicable GxPs.

· Maintains current knowledge of practices and trends in the area of Biologics, aseptic processing manufacturing, compliance, regulation, and related policies/procedures associated with FDA and other agency’s regulatory compliance guidelines, industry best practices and FDA current expectations to resolve client issues).

· Demonstrates the ability to synthesize solutions and recommend client improvements/changes.

· Effectively participates with consulting team members, clients, and government agency/industry representatives concerning drug research, development, manufacturing, FDA compliance, and the FDA drug submission/approval processes and post-approval regulatory matters.

· Works both collaboratively and independently to complete client projects; manages multiple assignments and tasks simultaneously; project management.

· Interacts successfully and contributes to client solutions with management in a timely manner; provides guidance, support, and direction to Associated Consultants.

· Demonstrates competence in communications – both written and oral – and communicates openly and freely with colleagues and clients, when required.

· Completes internal and external reporting paperwork on a timely basis.

· Supports the firm’s initiatives to build industry eminence and recognition and deliver quality work products.

Qualifications / Requirements include:

· Minimum ten years of experience in Biologics / Cell and Gene Therapy Quality Assurance, aseptic manufacturing operations and/or Quality Control

· Minimum five years of relevant management experience in the biopharmaceutical industry.

· Significant experience leading solution of complex compliance issues in industry and/or in consulting, this includes governance, financial, deliverables, etc.

· Possess a deep understanding of product development and/or manufacturing and has an excellent overall grasp of issues relating to the biopharmaceutical industry, preferably in the cell and gene space.

· Skilled in completing day-to-day project-related activities, formulating appropriate client recommendations, interacting with client representatives.

· Minimum of a bachelor’s degree preferably in a scientific/technical discipline such as Chemical Engineering, Biology, Cell Biology, Molecular Biology, Virology, Bioengineering, or Chemistry or in a discipline related to this position. Master's or Doctorate preferred.

· Ability to travel domestically and internationally.