Manager, Pharma Technology Transfer (Tablets)

Hims & Hers • Gilbert, AZ

68d

About The Position

The Manager, Pharma Technology Transfer (Tablets) will lead and manage the successful transfer of pharmaceutical tablet compounding processes between development and compounding sites, and/or between various pharmacy sites, ensuring consistent product quality, efficiency, and regulatory compliance. This role requires strong technical leadership, project management expertise, and in-depth knowledge of tablet compounding and process technologies and relevant regulatory standards.
Key responsibilities include strategic leadership and project management for tablet technology transfer projects, overseeing project plans and communication with stakeholders. The role requires applying expertise in tablet compounding and process technologies, like granulation, blending, compression, and coating, and providing technical support. Ensuring regulatory compliance with applicable regulatory standards, overseeing documentation, and supporting regulatory filings are also crucial. The Manager will manage and develop a team, fostering collaboration, and maintaining relationships with internal and external partners, including CMOs. This role requires up to 25% travel.
The Manager, Pharma Technology Transfer (Tablets) provides strategic leadership and technical expertise in the transfer of pharmaceutical compounding and process technologies from one site to another (internal or external). This role ensures successful scale-up, development, and commercialization of products while meeting quality, compliance, and regulatory requirements. They lead cross-functional teams, manage projects, and build relationships with stakeholders to facilitate smooth transfers and sustained supply.

Requirements

• A Bachelor's degree in a technical field (Pharmaceutical sciences, Chemical Engineering) is typically required, with a Master's or PhD preferred.
• Candidates should have at least 5-8 years of experience in pharmaceutical manufacturing or technology transfer, preferably with tablet manufacturing experience, and a minimum of 2 years in a leadership role.
• Demonstrated expertise in process design, validation, and optimization, along with a strong understanding of regulatory requirements (GMP, ICH), are essential.
• Excellent project management, communication, and leadership skills are also necessary.
• Strong technical background in pharmaceutical manufacturing processes, including scale-up, process validation, and equipment qualification.
• Proven project management experience, including managing complex projects and cross-functional teams.
• Excellent communication and interpersonal skills, including the ability to effectively communicate with technical and non-technical audiences.
• Experience in regulatory affairs and quality assurance, including knowledge of relevant regulations and guidelines.
• Strong leadership and team management skills, including the ability to motivate, mentor, and develop team members.
• Experience with technology transfer in a pharmaceutical or biotechnology setting, particularly with biologics, cell & gene therapies, or other complex modalities.
• Experience working with CMOs and other external partners.

Responsibilities

• Strategic Leadership and Planning: Develop and implement technology transfer strategies aligned with business goals, ensuring seamless transitions and optimal resource utilization.
• Technical Expertise and Oversight: Provide technical guidance on process validation, scale-up, equipment qualification, and regulatory requirements.
• Project Management: Lead and manage technology transfer projects, ensuring they are completed on time, within budget, and meet quality standards.
• Cross-Functional Collaboration: Collaborate with R&D, Quality Assurance, Regulatory Affairs, Supply Chain, and other departments to ensure successful technology transfer.
• Team Leadership: Lead and mentor a team of technology transfer professionals, fostering a collaborative and high-performing environment.
• Documentation and Compliance: Ensure comprehensive documentation, including manufacturing records, process descriptions, and risk assessments, to support regulatory filings and compliance.
• Risk Management: Identify and mitigate potential risks associated with technology transfer, developing and implementing appropriate mitigation strategies.
• Continuous Improvement: Identify and implement process improvements to enhance efficiency, product quality, and transfer timelines.
• Relationship Management: Build and maintain strong relationships with internal and external stakeholders, including production sites, CMOs, and regulatory agencies.
• Training and Knowledge Transfer: Ensure appropriate training and knowledge transfer to receiving sites, enabling them to operate the transferred processes effectively.
• Regulatory Compliance: Ensure all technology transfer activities comply with relevant regulatory requirements (e.g., cGMP, FDA regulations).

Benefits

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 11-50 employees