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Title:  Director, R&D, Advanced Therapies

Requisition ID:  44469
Date:  May 2, 2022
Location: 

Exton, Pennsylvania, US

Department:  R&D
Description: 

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

Job Summary:

 

West Pharmaceutical Services (West) is continuing to expand our Applied Research & Technology Scouting Team. The company has identified Advanced Therapies, including those modalities utilizing Adenovirus (ADV) / Adeno-Associated Virus (AAV), mRNA, DNA editing, and antisense oligonucleotides among other emerging technologies as an area of growth for the company. Our products are used in the primary containment and delivery systems and components are used by many of the leading pharmaceutical companies, including COVID vaccines (mRNA and viral) and two FDA approved AAV therapies in the US.

This role represents Research & Development’s most senior position in advanced therapies. The candidate for the role is expected to be highly collaborative and capable of interfacing both externally with clinicians, researchers, regulators, and biotech companies as well as internally with Sales, Marketing, and Scientific teams to identify the research vectors to address unmet for cell and gene-based therapies.

In collaborating across this wide array of stakeholders, the candidate would use the insights gained to lead all cell gene therapy-related research at West. This will include establishing best practice using current products as well as establishing future advanced therapy packaging requirements. Better understanding of mechanisms of action, formulation, manufacturing through to fill-finish and route of administration is required to inform West’s development decisions for next generation containment and delivery systems. The candidate will collaborate closely within R&D alongside colleagues focused on cell-based therapies, biomaterials, and Lipid Nanoparticle (LNP) technology, as well as build out research activity, establish new capabilities, and – where required – identify platform technologies that enable West to better address the advanced therapy field.

Suitable candidates will be expected to bring a substantial depth of subject matter expertise, knowledge of current developments in both research and industry, and will make a significant contribution to the R&D Team and the future scientific direction of West. 

 

Essential Duties and Responsibilities:

 

  • Build, establish, and maintain functional lab activities related to RNA/DNA-based drug manufacture, containment, and ancillary product expansion through evidence-based research performed externally and in-house. Able to translate project needs from external service providers to in-house services.
  • Collaborate and gain commitment with stakeholders internally within West as well as externally with research partners.  Accountable for the performance and results of multiple related technology development teams, both internal and external.
  • Translate highly technical results into cogent recommendations that will influence senior stakeholders. Provide clear communication, proactively communicate plans and progress while escalating risks, or needs to remove roadblocks for the team.
  • Impact West’s achievement of its long-term strategy objectives by setting the direction in the pursuit of new technology and novel product platforms.
  • Set organizational priorities, allocate resources, and development methodology to achieve department business objectives.
  • Provide subject matter expertise across the organization in the field(s) of gene-based therapies.
  • Travel to targeted scientific and research conferences to learn and present out research findings with intention of increasing West scientific reputation in novel fields.
  • Design project proposals to evaluate different technologies and ideas and test hypotheses across gene therapy manufacture, storage, and administration.
  • Create and maintain project plans to drive key decisions to ensure successful product technology embodiments. Capture project outputs in appropriate format including technical reports, presentation slides, research posters, invention disclosures, or as project permits.
  • Coach a driven team of technology developers and scientists, ensuring they have the skills, tools and opportunities needed continuously raise the bar on team performance.
  • Actively scout “state of the art” technology that applies to gene therapies and utilize conceptual and design thinking methodology to solve unique and complex problems with broad impact on the business by enriching the Development staff with cogent appraisals of overarching trends.
  • Perform other duties as assigned based on business needs.

 

Basic Qualifications:

 

  • Education: Masters in virology, immunology, biochemistry, genetics, and/or biomedical engineering or equivalent scientific discipline.
  • Experience: 15+ years of experience, can include time spent either in industry or graduate school.
  • In depth life sciences knowledge including experience through either academic or industry research of gene therapy and modes of gene delivery, i.e. understands scientific principles, industry landscape, production methods, routes of administration, underlying modes of action, etc.
  • Collaboration and Influence Skills:  The successful candidate must have demonstrated the ability to work effectively with a wide array of constituencies, including business peers, technical experts throughout the company, and outside partners.  They must have excellent interpersonal skills and be able to vary their style effectively to influence people in different situations.
  • Results Orientation:  The successful candidate must have a track record of delivering results, preferably in a corporate setting with multiple stakeholders from different organizations.  Participation in clinical research through to commercial launch of a gene-based therapy or equivalent, including knowledge of the translational challenges and regulatory filing requirements with the FDA.
  • Strategic Acumen:  Able to translate broad corporate strategies into clear, specific strategy, objectives. Demonstrable experience setting plans for the function of business units and associated activities; able to influence/drive projects across business functions. Analyze and evaluate experimental results to make well-reasoned strategic recommendations that are to be disseminated internally to inform future product development decisions at West.
  • Proficient in quality control of viral and non-viral vectors downstream of manufacture including, but not limited to, release testing, functional assays, and shipping/handling.
  • Demonstrable biological lab techniques related to BSL2 and/or GMP production of viral vectors.
  • Proven self-starter who runs towards critical issues, ambiguous requirements, or loosely defined challenges with a demonstrated ability to rally teams to achieve business results.
  • Excellent written and verbal communication and ability to articulately disseminate scientific research to a variety of different audiences, from expert through to non-technical.
  • Scientific publication track record and/or conference proceedings in a chosen field of expertise.

 

Preferred Knowledge, Skills and Abilities:

 

  • Education: PhD and/or Postdoctoral research in molecular biology, virology, immunology, genetics, and/or biomedical engineering, or an equivalent scientific or engineering discipline.
  • Expertise in RNA sequence experimental design and data analysis along with cell-based functional assays.
  • Existing established and academic and/or industry North American network of collaborators in gene therapy or related fields.
  • Candidate has prior knowledge of establishing research activity in a BSL-1/2 laboratory, including responsibilities for safety policies and procedures and ensure implementation and compliance.
  • Experience in any of the following areas: the testing or selection of primary containers used for drug containment, diverse knowledge over multiple routes of administration, aseptic filling techniques, and manufacturing of current gene-based therapies.
  • Demonstrated track record of generating intellectual property.
  • Must maintain the ability to work well with others in a variety of situations.
  • Must be able to multi-task, work under time constraints, problem solve, and prioritize.

 

Travel Requirements:

 

Must be able to travel domestically and internationally up to 15% of the time.


 

 

 

 

 

 

 

 

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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