17 days old

Associate Director R&D Unit

West Chester, PA 19380

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

 

Tevas Global Research & Development (R&D) organization is devoted to the development of new medicines, devices and combination products that provide meaningful therapeutic benefit to patients worldwide. Combining creativity, scientific rigor and our extensive knowledge on a broad range of technologies, our scientists, engineers, medical doctors and project leaders across the globe use their expertise to innovate novel biologics, biosimilars, small molecule specialty medicines, generics and over-the-counter therapies.

Job Description

The current position will be a key leadership role in DPDO to support the development of Teva innovative and biosimilar product pipeline for manufacture into drug product reporting into the head of the department.  The incumbent will be responsible for formulation development initial and cycle 2 including representing DPDO on matrix teams, writing relevant sections of submissions and managing a team of scientist with project leadership responsibilities to ensure project deliverables are met. In addition to working closely with the operations team to progress the drug product to commercial and the senior leadership team of DPDO to develop strategy to progress drug product development.

 

Responsibilities  
    Responsible for formulation development initial and cycle 2 including experimental design, protein characterization and execution and/or review of all associated protocols and technical reports for biosimilar and innovative biologic programs.
    Brings to implementation high-through-put formulation development platform.
    Evaluation of new formulation technology to enable high concentration of proteins.
    Represents DPDO on matrix team to progress the pipeline including interfacing with regulatory and nonclinical and clinical organization to develop appropriate regulatory submissions and respond to agency questions and develop appropriate in-use studies.
     Collaborate with the operations group in DPDO to provide expertise on the product to ensure the appropriate manufacture of GMP DP to effectively and efficiently progress the Teva biologics innovative and biosimilar pipeline.
    Collaborates with the Combination Products Group for the progression of DP in devices (i.e. PFS, NSD, AI)     providing knowledge of the characteristics of the drug product and providing expertise to any collaborative study design for products delivered via devices.
    Collaborates with direct manager and other managers in DPDO as appropriate to develop strategy for DPDO.
    Contribute to relevant DP formulation sections in regulatory submission and response to questions as DPDO line reviewer or author if needed.
    Contribute to resource planning, objective setting and any other business related processes as appropriate.
    Leadership in cross department initiatives.
    Management of at least three scientists of various experiences.  Including providing opportunities for development, advising, coaching and mentoring.
    Collaborate across CMC with the DS process development, analytical and quality control groups as appropriate.
    Represent DPDO as it relates to external technical collaborations.
    Represent DPDO when manager is not available.
 

Relocation Assistance may be available 

Qualifications

 

Minimum Qualifications
    Bachelors in chemistry, biology, pharmaceutical sciences, biochemistry, chemical engineering or other related discipline with a ~20 years of experience in biologics that includes formulation and analytical characterization of mAbs, or Masters in a related discipline with ~15 years, or Ph.D. in a similar discipline with ~10 year of experience.
    Understanding with hands on experience of analytical techniques as it relates to formulation development including: using physical and biochemical characterization methods, such as general appearance, opalescence, osmolality, particulate analysis (MFI and HIAC), viscosity, HPLC, DLS, DSC, CD and FTIR.
    Experience using statistical programs such as design of experiments or JMP to build efficient formulation development designs and be able to interpret the results of those designs to make formulation decisions.
    Experience managing scientists.
    Experience authoring and reviewing regulatory submissions related to CMC activities.
    Current knowledge of regulatory guidelines related to biologic pharmaceutical development, characterization, and comparability including ICH guidance and cGMP.

 

Preferred Qualifications
    Experience writing guidance documents for technical processes as it related to biological drug product.
    Experience in the creation and implementation of high-through-put formulation development.
    Experience with extractable and leachable programs as it relates to drug product.
    Experience working in a matrix team to progress biologic products.
    Experience collaborating with process development, analytical and other relevant organizations for the progression of biologics to commercial.
    Ability to develop plans and deliver results in a dynamic changing environment.
    Ability to manage multiple partners and interfaces to progress project objectives.
    Highly motivated individual, with ability to work in a team environment and build productive relationships within and across departments.
    Excellent project management, verbal/written communication, and interpersonal skills.

Function

Research & Development

Sub Function

Drug Development and Preclinical Studies

Reports To

Senior Director, Biologics CMC 

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to  support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Categories

Posted: 2021-04-26 Expires: 2021-05-27

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Associate Director R&D Unit

Teva Pharmaceuticals
West Chester, PA 19380

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