Senior Manager, Drug Substance and Drug Product Technology Transfer New Haven United States,
This position is the process and analytical technical lead for drug substance and drug product manufacturing and testing within Alexion’ s external network. Key areas of expertise for this position include oversight of process and analytical method development, process and product characterization, process validation, and analytical method validation, process and analytical transfer and manufacturing of drugs substance and sterile parenteral product with an emphasis on process and analytical transfer to CRO/CMO, manufacturing support and project management.
The individual will serve as a subject matter expert as it relates to any technical, regulatory and quality aspects of biological drug substance and drug product development, manufacturing and testing, and will lead the technical support activities of manufacturing of products at Alexion’s network of drug substance and drug product contract manufacturers. This incumbent will represent Global Product Development in cross-functional project teams with senior members of process development, technical services, quality control, quality assurance, supply chain.
The individual will provide technical leadership in handling the GMP manufacturing quality systems, completing projects and supporting regulatory submissions and inspection. The qualified candidate will manage and coordinate technically diverse activities that include process and analytical development, technical transfer, technical assessment and change management, phase appropriate studies, and CMC inputs for regulatory filings. Additional responsibilities include leading facility fit modeling, gap analyses and risk assessments for drug substance and drug product candidates and contributing to establishing phase appropriate designations for process parameters and attributes for a manufacturing process. The successful candidate will have a key understanding of ensuring biological process control strategy, sterility assurance, and product integrity and will establish a clear communication plan to ensure that all team members, partners, sponsors and stakeholders are kept informed of progress. Understanding of scale–up of drug substance and drug product manufacturing processes and parameters that are critical to safe, robust, consistent manufacture of drug product is essential.
- Execute process development and technology transfer projects to internal or external manufacturing facilities. Ensure project delivery jointly with the technical transfer and development teams.
- Provide Subject Matter Expertise on technical and operational knowledge of biological drug substance (initially microbial based but with scope for future projects that are manufactured using mammalian expression systems) and sterile product manufacturing/drug product device capabilities. Perform risk based assessments to detect quality and technological risks. Partner with internal QA and external facilities to manufacture and release clinical batches on agreed schedules. Prevent issues and ensure timely closure and approval of deviations, OOS, CAPAs and Change Controls
- Establish and coordinate continuous communication with Quality Assurance, Quality Control, Process Development and Analytical Sciences and Supply Chain teams to ensure efficient tech transfer of Alexion's clinical and commercial manufacturing activities.
- Working closely with Research, Process Development, Manufacturing, Engineering and Quality organizations, coordinate the phase appropriate development/engineering studies. Author or review associated technical reports and manufacturing history documentation.
- Author/Review Tech Transfer Work Plan/Protocol, Process Description and Control Strategy Documents.
- Review process development and process characterization master plans, protocol and reports. Understanding of DOE and statistical tools to understand design space is required.
- Oversee analytical method development, phase appropriate validation, and transfer conducted by CROs for future biopharmaceutical programs
- Oversee analytical life cycle management and post marketing commitment efforts for future biopharmaceutical commercial products
- Oversee DS and DP impurity characterization and control strategy setting
- Oversee analytical testing by CMOs and CROs for biopharmaceutical candidates and raw materials; assess assay performance and stability trending
- Oversee reference standards qualification and management
- Lead the specification and shelf life setting for biopharmaceutical candidates
- Evaluate and establish degradation pathway and control strategy for biopharmaceutical candidates
- Provide technical content for regulatory submissions with respect to analytical methods
- Support statement of work/purchase orders for technical transfer activities to CDMOs.
- Search relevant literature on process improvement to support and participate in laboratory experiments planning, monitoring and analysis.
- Coordinate manufacturing floor support for general oversight of technical transfer activities at external manufacturing facilities.
- Ensure open communication and effective collaboration of all involved functions and external parties. Ensure reporting to Leadership and internal stakeholders are done in a timely and quality fashion.
- Ensure that day to day tracking and progress is maintained to meet overall project timelines
- Manage the impact of scope changes during technical transfer activities
- Coordinate information and material transfers to and from external manufacturing facilities
- Partner with internal QA and external facilities to prevent issues and ensure timely closure and approval of deviations, OOS, CAPAs and Change Controls and support closure of Trackwise records when needed.
- Coordinates and provides manufacturing floor support for general oversight of technical transfer activities at external manufacturing facilities
- Review of process validation documentation (PV master plan, protocols, reports)
- Review IND/IMPD, BLA/CTD and other technical documents for regulatory agency submissions and support regulatory agency inspections.
- Ensures open communication and effective collaboration of all involved functions and external
- Global role requiring domestic and international travel to CMO/CRO (~30%)
- 10-12 years of biologics process and product development, analytical method development and validation, and tech transfer experience in biopharmaceutical organization.
- Experience with microbial and mammalian expression systems.
- Experience with project management of technical transfer. Established previous experience as project leader for tech transfer of DS/DP process.
- Experience in collaborating with contract manufacturing companies and proven track record in coordinating large and/or complex project teams.
- Experience in project managing small and mid-sized projects in conjunction with a CMO
- Strogn knowledge of current regulatory guidelines and cGMP requirements for clinical and commercial biopharmaceutical manufacturing (DS/DP/testing) and ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant
- Must be able to analyze data using statistical methods
- Resolve manufacturing issues and discrepancies in collaboration with Quality organizations internally and externally
- Must be flexible and able to manage multiple tasks effectively while prioritizing appropriately
- Ability to drive for results independently and adapt to rapidly changing priorities
- Excellent communication (oral and written) and attention to detail; ability to present and defend technical and scientific approaches and decisions in both written and verbal form to internal and external partners
- Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections
- Ability to influence others without direct authority and communicate with all levels of the organization
- Ability to participate in global cross-functional teams and work effectively in a highly matrix team environment
- Must be flexible and able to manage multiple tasks effectively while prioritizing appropriately.
- Excellent analytical, problem solving, planning and organization skills. Proven ability to work under pressure
- Experience preparing regulatory submissions and responding to regulatory inquiries
- Expertise with various biopharmaceutical unit operations, process development, pilot and/or Manufacturing scale operation.
- Experience with scale up/scale down of biopharmaceutical unit operations.
- Strong appreciation for sterility assurance as it relates to parenteral product
- Exposure to life-cycle management of commercial products.
- Proven track record in coordinating large and/or complex project teams.
- Strong understanding of pharmaceutical industry (regulatory environment) and clinical supply chain processes.
- Good understanding of application of statistical techniques for data analysis and process understanding.
- Additional knowledge in one or more areas in regards to: product characterization methods, comparability assessments, process validation, bioequivalency/immunogenicity studies, etc, for parenteral formulations is desirable.
A successful candidate will typically hold a BS, MS or Ph.D. degree in an Engineering or Scientific discipline from an accredited university.
New Haven, CT, United States
Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World’s Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts’ Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.
Alexion’s aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.
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