Director, Chemistry - Emeryville, CA | Biospace
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Director, Chemistry

Catalent Pharma Solutions, Inc.

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Location:
Emeryville, CA
Posted Date:
5/18/2017
Position Type:
Full time
Job Code:
0021556
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:
Chemistry, Director,

Job Description


Catalent is seeking a Director, Chemistry who will be responsible for overseeing, expanding and optimizing the Company’s chemistry resources.  This position will be responsible for the implementation of these resources to the Company's proprietary toxin-linkers, bioconjugation technology and biotherapeutic assets to meet pre-clinical through commercial bioconjugate development, both internally and with partners/customers.  This position will report directly to the Global Head of R&D at Catalent’s Emeryville, CA site.

Position Summary

Redwood Bioscience, a fully owned subsidiary of Catalent Pharma (Catalent Biologics), has developed a protein-chemical engineering technology to produce the next-generation of antibody-drug conjugates (“ADCs”) and other semi-synthetic biotherapeutics. The company’s proprietary SMARTagTM site-specific protein modification technology, novel conjugation chemistry and proprietary cytotoxin-linkers enable the generation of homogeneous bioconjugates engineered to enhance potency, safety and stability. The technology employs natural post-translational modifications found in human cells to site-specifically create one or more aldehyde tags on protein molecules. These chemical handles are then stably conjugated to cytotoxic payloads to prevent their systemic release. The SMARTagTM platform provides precise payload positioning and defined stoichiometry of payload–protein ratios. The control afforded by the technology also enables identification of superior drugs from libraries of differentially designed conjugates.

Key Responsibilities

o   Lead the chemistry support for research projects, development, CMC, formulation development and process transfer efforts, working cross-functionally with biology, analytical and bioconjugation teams.
o   Implement research strategies to meet research goals and project outcomes including hands on laboratory work
o   Set a culture of achievement with internal team efforts that is execution and results oriented.
o   Keep abreast of best industry practices for ADC chemical methods and regulatory requirements
o   Be responsible for overseeing/reviewing the appropriate sections of any regulatory filings with Partners as requested or required.
o   Assist in establishing, maintaining and managing collaborations with strategic partners, including internal sites within the Catalent Biologics organization
o   Play a key role in meetings with current, future and potential corporate partners and regulatory agencies as well as in industry conferences.
o   Work with the company’s team and advisors to foster the expansion and protection of the Company’s intellectual property portfolio.
o   Manuscript preparation
o   Contribute technical due diligence and CMC assessments on any licensing and collaboration opportunities.

About Catalent

Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients globally. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients around the world.

Catalyst + Talent. Our name combines these ideas. From drug and biologic development services, to delivery technologies to supply solutions, our highly skilled and dedicated global team of over 9,500 is passionate about improving health and wellness by combining their personal expertise and advanced technologies to advance science and supply products of the highest quality to customers and patients around the world.

Our VISION is to be the world’s most trusted, reliable and innovative drug development and delivery partner by upholding the highest industry standards and exceeding customer expectations while driving strong, sustained growth for the company.

Our MISSION is to develop, manufacture and supply products that help people live better, healthier lives.

OUR VALUES are at the foundation of everything we do:

•          Patient First:  We put patients at the center of our work to ensure the safety, reliable supply and optimal performance of our products
•          Customer Dedication: We strive to exceed our customers’ expectations every day
•          People: We are committed to the growth, development and engagement of our people
•          Innovation: We develop and apply innovative solutions, superior technologies and continuously improved processes
•          Integrity: We demonstrate respect, accountability and honesty in every interaction
•          Excellence: We have a passion for excellence in everything we do.

Requirements


o   PhD in chemistry field required with 10-15 years of industry experience
o   The candidate must have significant experience with ADCs and bioconjugates
o   Track record of success as an individual contributor and leader/manager at a biopharmaceutical company. Ideally, the candidate will have worked in both large and early stage firms.
o   Demonstrated expertise in multi-step synthesis, reaction optimization and compound purification.
o   Competency with modern spectroscopic methods applied to small molecule structure determination including 1H NMR and mass spectroscopy is required.
o   Background in developing the information package for CMC and associated technologies required for regulatory submissions. Candidates with regulatory filing experience, along with interaction with regulatory agencies (domestic and international) will be favored.
o   Success as a participant in partnership discussions
o   Experience with project goal/milestone setting and project management with skill in working across broad functional teams.
o   Background in oncology drug target selection and preclinical development a plus.
o   Previous employment at an emerging biotechnology company and at a large pharmaceutical company desirable.
o   Strong presentation skills: one on one and groups.
o   Strong track record of publishing data in peer-reviewed scientific journals

Personal characteristics

o   A high degree of personal and professional integrity
o   Strong interpersonal, leadership and communication skills
o   Ability to deliver high quality results in a resource constrained environment
o   A high energy level and entrepreneurial motivation
o   Flexible, comfortable with aggressive timelines and able to adjust to changing situations, providing ideas and solutions.