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Senior Director, Technology Transfer and Compliance, Synthetic Product Development

Location Дублин, Ленстер, Ирландия Идентификатор вакансии R-200678 Дата публикации 05/25/2024

This is what you will do:

Alexion’s Synthetic Product Development (SPD) organization is seeking an experienced CMC professional to lead the planning and execution of technology transfer activities in support of a diverse synthetics portfolio, spanning first-in-human clinical studies through first commercial launch. The incumbent will lead and direct a cross-functional team of technology transfer professionals, enabling pharmaceutical manufacturing processes spanning small molecule, peptide, and oligonucleotide modalities. The Senior Director, Technology Transfer and Compliance, will bring to bear deep expertise in manufacturing science and technology, project planning, cGMPs and regulatory guidances to enable successful technology transfer, validation, and pre-approval inspections for manufacturing processes encompassing synthetic drug substances as well as oral drug products. The incumbent will report directly to Alexion’s Head of Synthetic Product Development and will be a member of the SPD Leadership Team. The incumbent will partner extensively with Alexion team members in Clinical Supply, QA, Regulatory Affairs, and Technical Operations, will represent SPD at internal governance bodies, will have broad accountability for procedural and regulatory compliance throughout the technology transfer process, and will represent Alexion on joint program teams and joint steering committees with our external manufacturing partners.

You will be responsible for:

  • Directing technology transfer, manufacturing science and technology support across the Alexion synthetics portfolio, with a remit spanning first-in-human clinical studies to successful licensure.
  • Coaching, mentorship, and career development for a hard-working team of technology transfer professionals.
  • Holistic planning of technology transfer activities across the Alexion synthetics portfolio, with an ability to anticipate and communicate key risks, and develop forward-thinking risk mitigation strategies.
  • Developing comprehensive technology transfer, scale-up, and process validation plans for synthetic drug substances and oral drug products, along with associated analytical activities.
  • Gaining endorsement from internal governance bodies and chartering cross-functional technology transfer teams to enable implementation.
  • Assisting and mentoring colleagues for efficient technology transfer to internal and external manufacturing sites, in a phase appropriate manner.
  • Providing subject matter expertise to enable authoring of Module 3 content for regulatory submission documents that convey phase-appropriate scientific understanding, spanning IND/IMPD through NDA/MAA.
  • Providing subject matter expertise for regulatory interactions including information requests, inspections, and audits.
  • Forging alignment on roles and responsibilities, quality and compliance expectations, timelines, establishing channels for information sharing, and defining workflows for review and approval of documentation between Alexion technology transfer teams and our external manufacturing partners.
  • Partnering closely with SPD technical authorities in developing robust plans to ensure technical readiness of CMOs for process validation, pre-approval inspection, and commercial launch.
  • Forging close partnerships with Alexion QA to ensure rigorous adherence to Alexion procedural and governance requirements throughout the technology transfer planning and implementation process.
  • Proposing key performance indicators to monitor the health of our technology transfer programs, and providing visibility of these metrics for governance bodies, joint program teams, and joint steering committees.

You will need to have:

  • Ph.D. in chemical engineering, pharmaceutical science, organic chemistry, or related scientific field with minimum 15 years cumulative experience in the pharmaceutical industry, and minimum 10 years direct experience in technology transfer, cGMP manufacturing, process validation, commercial licensure, and pre-approval inspections.
  • Intimate familiarity with cGMPs and pharmaceutical regulatory guidances.
  • Demonstrated ability to plan and lead complex technology transfer projects, and the ability to handle activities and timelines at CMOs.
  • Demonstrated ability to lead cross-functional teams in matrixed organizations.
  • Deep understanding of the design, development, optimization, tech transfer, and scale-up of pharmaceutical manufacturing processes.
  • Expertise to remain abreast of technical, compliance, and regulatory trends pertaining to small molecules, peptides, and oligonucleotides, and the ability to evaluate new and emerging manufacturing technologies.
  • Up to 25% travel, with ability to work independently from remote locations.
  • The duties of this role are conducted in an office environment.  As is typical of an office-based role, employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
  • The duties of this role may also require periodic work in a pharmaceutical manufacturing environment. As is typical for such roles, employees must be able, with or without an accommodation to frequently lift/carry 15/30 pounds unassisted/assisted; stand for prolonged periods of time; walk and move for prolonged periods of time; climb stairs or ladders; gown/degown PPE. In addition, employees in this role must be able, with or without an accommodation to pass a medical evaluation; wear a respirator while maintaining a tight-fitting seal to the face.

We would prefer for you to have:

  • Prior experience with continuous manufacturing technologies.
  • First-hand experience with technology transfer of multi-step continuous processes and coordinating cGMP implementation at CMOs.
  • Prior experience with technology transfer, scale-up, and cGMP implementation of solid phase peptide synthesis and/or solid phase oligonucleotide synthesis at external manufacturing sites.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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