CMC Strategy Consultant
at Precision Life Sciences
Boston, Massachusetts, USA -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 10 Nov, 2024 | Not Specified | 11 Aug, 2024 | N/A | Biotechnology Industry,Biochemistry,Chemical Engineering,Commercialization,Regulatory Requirements | No | No |
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Description:
Position Overview: Our client is seeking an experienced Part-Time CMC (Chemistry, Manufacturing, and Controls) Strategy Consultant to lead the strategic planning and execution of CMC activities for our Phase 3 clinical trials and potential commercial operations in the US and EU. The ideal candidate will possess deep expertise in CMC strategy and a track record of successfully managing integrated timelines, resource planning, cost estimation, and risk management in a pharmaceutical or biotechnology setting. This candidate will be setting the overall strategy and working with their internal team to execute.
QUALIFICATIONS:
- Experience: Minimum of 8-10 years of experience in CMC strategy and management within the pharmaceutical or biotechnology industry. Proven track record in managing complex CMC projects, particularly for late-stage development and commercialization.
- Education: Bachelors degree in a relevant scientific or engineering discipline (e.g., Chemistry, Biochemistry, Chemical Engineering). Advanced degree (e.g., Masters, PhD) preferred.
- Skills: Strong understanding of CMC processes, regulatory requirements, and industry standards. Excellent project management, analytical, and problem-solving skills. Ability to effectively communicate and collaborate with cross-functional teams and external partners.
Attributes: Strategic thinker with a proactive approach to problem-solving. Ability to work independently and manage multiple priorities in a fast-paced environment
Responsibilities:
- Strategic Leadership: Develop and oversee the CMC strategy for Phase 3 clinical trials and potential commercialization in the US and EU markets. Ensure alignment with overall program objectives and regulatory requirements.
- Integrated Timeline Management: Create and maintain comprehensive CMC project timelines that integrate various activities, milestones, and deliverables. Monitor progress and make adjustments as needed to ensure timely project execution.
- Resource Planning: Assess and allocate resources effectively to support CMC activities, including coordination with internal teams and external partners. Identify and address gaps.
- Cost Management: Develop and manage budgets related to CMC activities. Provide cost estimates, track expenditures, and identify opportunities for cost savings.
- Risk Assessment: Identify potential risks associated with CMC activities and develop mitigation strategies. Proactively address issues to minimize impact on project timelines and objectives.
- Regulatory Strategy: Support regulatory submissions and interactions with health authorities. Ensure CMC strategy aligns with regulatory requirements and best practices for both US and EU markets.
- Cross-Functional Collaboration: Collaborate with internal teams (e.g., RD, clinical, regulatory) and external partners (e.g., contract manufacturing organizations, consultants) to ensure successful execution of CMC plans.
- Reporting and Communication: Provide regular updates to senior management and stakeholders on CMC strategy, progress, risks, and key issues. Prepare and present reports as needed.
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
A relevant scientific or engineering discipline (e.g chemistry biochemistry chemical engineering
Proficient
1
Boston, MA, USA