Analytical Development Scientific Integrator, Biotherapeutics

6084-Janssen Research & Development, LLC Legal Entity; Malvern (Chester County); On-site; USD 117,000 - 201,000; Full time

Job summary

Johnson & Johnson is seeking an Analytical Development Scientific Integrator in Biotherapeutics to lead cross-functional analytical programs early in development. You will drive technical strategies for mAbs, multispecifics, and fusion proteins within the AD group and represent Analytical Development on CMC teams.

You will coordinate a matrix of scientists and interact with Manufacturing, Regulatory, Quality, Discovery, and external partners to ensure high-quality regulatory submissions and

Qualifications

• Master1s degree in Analytical Chemistry, Biochemistry, Biological Science or related and 8+ years in biopharmaceutical development.
• PhD in Analytical Chemistry, Biochemistry, Biological Science or related with 3+ years in biopharmaceutical development preferred.
• At least 2 years on cross-functional CMC teams and ability to lead in a matrix environment.
• Knowledge of biotherapeutic development and analytical strategy including analytical protein characterization, separation techniques, and biological potency assays.
• Experience with development and registration of protein conjugates and addressing health authority questions.
• Strong leadership, communication, interpersonal, and negotiation skills with cross-team collaboration.

Responsibilities

• Provide strategic and technical leadership in analytical development and lead a cross-functional AD team.
• Represent AD on the CMC team and accountable for all AD project deliverables.
• Lead the execution of CQA assessment, analytical control strategy, and product specifications for programs.
• Lead analytical reviews of programs at governance meetings with SMEs.
• Accountable for submission of complete, consistent, and high-quality regulatory documents to health authorities.
• Communicate project status/resources/budget/issues to senior management.
• Accountable for project risk management including mitigation strategies and escalation.
• Interact with Manufacturing, Regulatory, Quality, Discovery, and external partners.

Skills

Leadership

Communication

Interpersonal skills

Negotiation

Collaboration

Matrix environment

Education

Master's degree in Analytical Chemistry/Biochemistry/Biological Science

Ph.D. in Analytical Chemistry/Biochemistry/Biological Science (preferred)

Job description

Company Overview

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

Job Details

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

Role Summary

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.

Job Equity Statement

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected under federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.

Required Skills

Required Skills: Preferred Skills:

Pay & Benefits

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 period
• 10 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