Associate Director, Drug Product Development
4 weeks ago
Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
Teva's 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.
Located in West Chester, PA, Biologics CMC is a division of Teva Pharmaceuticals responsible for the development of biologics. The rapidly growing staff of Biologics CMC specializes in the development of innovative biologics, biosimilars, and extended half-life bio-betters. We currently are developing products in various stages of clinical development from IND through BLA filing. Drug Product Development (DPD) is a function within Biologics CMC dedicated to development of formulation, drug product manufacturing process, and process tech transfer to GMP manufacturing sites.
Associate Director is a key leadership role in DPD reporting into the head of the department and managing a team of scientists with project leadership responsibilities. The Associate Director is responsible for drug product development for Teva biologics products to ensure project deliverables are met.
This position is located out of West Chester, PA and the person hired for this role will be required to be onsite 5 days a week
How you'll spend your day
- Responsible for biologics drug product development including manufacturing process tech transfer to support PPQ and commercial manufacturing.
- Represent DPD on matrix teams to progress the pipeline including interfacing with regulatory and nonclinical and clinical organization to develop appropriate regulatory submissions and respond to agency questions.
- Collaborate with the Combination Products Group for the development of 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.
- Contribute to relevant Drug Product sections in regulatory submission and response to address regulatory questions.
- Contribute to resource planning, objective setting and any other business-related processes as appropriate.
- Provide leadership in cross department initiatives.
- Manage scientists of various experiences. Including providing opportunities for development, as well as advising, coaching and mentoring.
- Represent DPD as it relates to external technical collaborations
Minimum Qualifications
- Bachelor's in chemistry, biology, pharmaceutical sciences, biochemistry, chemical engineering or other related discipline with 15 years of experience in biologics development, or Master's in a related discipline with 10 years' experience, or Ph.D. in a similar discipline with 7 years of experience.
- Understanding with hands on experience of biological drug product development, including formulation and manufacturing process development.
- Experience in leading manufacturing process tech transfer is required.
- At least 3 years of people management experience.
- Minimum 3 years of experience working in a matrix team to progress biologic products.
- 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.
- Experience working in a matrix team to progress biologic products.
- Ability to develop plans and deliver results in a dynamic changing environment.
- 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.
Enjoy a more rewarding choice
We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.
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's Equal Employment Opportunity Commitment
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.
Important notice to Employment Agencies - Please Read Carefully
Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
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