Employee Consultant/Biologics (Individual Contributor Role)
Lachman Consultants, the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries, is seeking: Employee Consultant/Biologics (Individual Contributor Role)
The responsibilities of the Consultant include responding to complex client issues and developing project deliverables. Individuals in the role of Consultant 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. Having expertise in a specific area related to complex dosage forms or complex active pharmaceutical ingredient 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. This individual also provides guidance on complex issues relating to client projects.
The Consultant is comfortable working in a client-oriented, professional services environment, and possesses at least ten years of pharmaceutical industry regulatory experience. FDA regulatory experience a plus.
The Consultant is skilled at 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 Consultant 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 Consultant 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:
- Biologics, cell, and gene therapy knowledge and expertise.
- Understanding of biologics / ATMPs and associated processes.
- Quality Operations / Quality Systems – implementation of QA and QC systems and processes for biologics/gene therapy products including testing and release of products.
- Aseptic biologic manufacturing of intermediates, bulks, and finished products.
- Filing requirements for biologics and gene therapy products.
- Knowledge of FDA, EU and International regulations, EU, and US and industry best practices regarding documentation systems, design control, change control, product specifications and applicable GxPs.
- Maintains current knowledge of practices and trends in the areas of drug development, manufacturing, compliance, regulation, laboratory, and related policies/procedures associated with FDA and other agency’s approvals for drugs and can convey this knowledge to other Lachman consultants.
- Responds adeptly to client issues and interprets data relating to pharmaceutical development, FDA submissions, manufacturing, and/or regulatory questions; effectively handles and resolves complex client issues (applying 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 Associate 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 relevant management experience in the biopharmaceutical industry.
- Possesses a deep understanding of product development and has an excellent overall grasp of issues relating to the biopharmaceutical industry, specifically 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. Masters or Doctorate preferred.
- Ability to travel multiple days at a time both domestically and internationally.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Disclaimer: This is a representative description of the job and may not be 100% inclusive of all the responsibilities and tasks required in the job.