Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Biotherapeutics R&D
Job Category:Scientific/Technology
All Job Posting Locations:Malvern, Pennsylvania, United States of America, Raritan, New Jersey, United States of America
Job Description:Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for Analytical Development Scientific Integrator, Biotherapeutics.The Therapeutics Development, and Supply (TDS), Analytical Development (AD) group is seeking a Principal Scientist for an Early Development Analytical Scientific Integrator role. The candidate will lead cross-functional analytical teams for biopharmaceutical programs in early stage clinical development for monoclonal antibodies, multispecifics, fusion proteins, and protein conjugates. This individual will provide technical and strategic leadership to analytical teams and represent Proteins Development AD on the Chemistry, Manufacturing, and Controls (CMC) team(s).
Principal Responsibilities- Provide strategic and technical leadership in analytical development and lead a cross-functional scientific team consisting of members from each of the AD sub-functions.
- Represent AD on the CMC team and accountable for all AD project deliverables.
- Lead the execution of critical quality attribute (CQA) assessment, analytical control strategy, and product specifications for programs.
- Lead the analytical review of programs at governance meetings with support from subject matter experts.
- Accountable for submission of complete, consistent, and high-quality regulatory documents to health authorities.
- Effectively communicate project status/overview, resources, budget, and issues to senior management.
- Accountable for project risk management including development of appropriate mitigation strategies and escalation to senior management.
- Interact with and influence various stakeholders outside of DPDS including Manufacturing, Regulatory, Quality, Discovery, and external partners.
Qualifications- A minimum of a Master's degree in Analytical Chemistry, Biochemistry, Biological Science, or a related scientific discipline with at least 8 years of experience in biopharmaceutical development is required. A Ph.D. in Analytical Chemistry, Biochemistry, Biological Science, or a related scientific discipline with at least 3 years of experience in biopharmaceutical development is preferred.
- A minimum of 2 years of experience on cross-functional CMC teams or analytical sub-teams with the ability to lead and execute complex plans/deliverables in a matrix environment is required.
- Knowledge of biotherapeutic development and analytical strategy including analytical protein characterization, separation techniques, and biological potency assays is required.
- Experience with the development and registration of protein conjugates is a plus
- Experience authoring and reviewing CMC sections of clinical trial applications (INDs/IMPDs) and addressing health authority questions is required.
- Must have strong leadership, communication, interpersonal, and negotiation skills and be able to collaborate across teams in a matrix environment
Required Skills:Preferred Skills:The anticipated base pay range for this position is :$117,000.00 - $201,250.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
