Director, Technology Transfer and Compliance (analytical), Synthetic Product Development

This is what you will do:

Alexion’s Synthetic Product Development (SPD) organization is seekingan experienced analytical professional to lead the planning and execution of analytical technology transfer activities in support of a diverse synthetic portfolio, spanning first-in-human clinical studies through first commercial launch. The incumbent will be part of a cross-functional team of technology transfer professionals,enablingthe manufacturingand testing of drug substances and drug products, spanning small molecule, peptide, and oligonucleotide modalities. 

The Director, Technology Transfer and Compliance (analytical), will leverage deep expertiseinanalytical science, project planning, cGMPs and regulatory guidance to enable successful method development, transfer and validation. The incumbent will report directly to Alexion’s Senior Director of Tech Transfer and Compliance (TT&C). The incumbent will partner extensively with Alexion stakeholders in R&D, Clinical Supply, QA, Regulatory Affairs, and Technical Operations, and will represent SPD at the relevant internal CMC Team(s) and will represent SPD on all related Joint Process Team (JPT) meetings with our external manufacturing/testing partners.

You will be responsible for: 

• Directing analytical technology transferactivities across the Alexion synthetics portfolio, with a remit spanning first-in-human clinical studies to successful licensure.

• The transfer of information and knowledge between SPD colleagues and the internal CMC Team(s) as well as Alexion’s external partners. The incumbent will be the single point of contact between SPD analytical scientists and the internal CMC team(s) and external JPT team(s), so excellent commutation and planning skills are essential.

• Ensuring all methods are fit for purpose and suitablyvalidatedfor their stage of development.

• Oversee the internal and external development/validation of analytical methods and execute their transfer as needed. 

• Review and approve all analytical technology transfer protocols and reports, external method SOPs and investigation protocols/reports, SOPs, and policies.

• Develop and maintain strong and effective relationships with both internal and external partners, including internal/external manufacturing/testing partners, QA, Commercial Operations, R&D and Regulatory Affairs, to ensure corporate goals are met.

• Defining strategies and ensuring implementation with regard to reference standard management and stability/hold studies 

• Holistic planning of analytical technology transfer activities across the Alexion synthetics portfolio, with an ability to anticipate and communicate key risks, and develop nimble risk mitigation strategies.

• 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, quality and compliance expectations, timelines, establishing channels for information sharing, and defining workflows for review and approval of documentation both internally and with our external partners.

• Partnering closely with SPD technical experts in developing robust plans to ensure technical readiness of external partners for method/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.

• Tracking and owning 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:

• A Master’s or Ph.D in analytical chemistry or related disciplines with a minimum of 10 years’ work experience in the pharmaceutical/biotechnology industry 

• Demonstrated leadership and managerial skills are a must with a minimum of 5 years’ management experience in an analytical function.

• Intimate familiarity with cGMPs and pharmaceutical regulatory guidances.

• Excellent troubleshooting skills in analytical areas

• Excellent written and verbal communication skills and demonstrated ability to work effectively in cross functional teams

• Ability to represent Alexion Pharmaceutical’s interests, objectives and policies in a responsible manner to external parties

• Demonstrated ability to plan and lead complex technology transfer projects, and the ability to manage activities and timelines at CMOs.

• Demonstrated ability to lead cross-functional teams in matrixed organizations.

• Expertiseto remain abreast of technical, compliance, and regulatory trends pertaining to small molecules (and ideally peptides, and oligonucleotides) and the aptitude to evaluate new and emerging technologies.

• Up to 10% travel, with ability to work independently from remote locations.

• The duties of this role are generally 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 accommodationto: pass a medical evaluation; wear a respirator while maintaining a tight-fitting seal to the face.

We would prefer for you to have:

• Prior analytical TIDES experience

• Pre-approval inspection experience 

• Project management certification

• Evidence of continues learning e.g. MBA, QP status.