Principal Scientist Pharma Prod RD

Johnson & Johnson Innovative Medicine; Beerse; On-site; EUR 80,000 - 138,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Well-being reimbursement

Insurance plans

Service awards

Job summary

Johnson & Johnson Beerse is seeking a Principal Scientist (ST7) Scientific Integrator to lead a DPRD sub-team and integrate Drug Product development activities across PK, CMC and process development. You will align strategies with CDT, PPDS and manufacturing teams to deliver robust formulations for clinical and late-stage programs.

The role requires a PhD or Master’s with 5–10 years in Drug Product development, strong leadership, and the ability to influence cross-functional partners.

Qualifications

• Master's Degree or PhD in Chemistry, Pharmacy, Biochemical Engineering, Chemical Engineering or a related field with five to ten (5-10) years of experience or the equivalent training/experience
• Competencies and experience in Drug Product development within the pharmaceutical industry. You demonstrate a high level of technical understanding.
• Experience in scale up of manufacturing processes and technical transfer of projects into commercial manufacturing.
• Drug Product development experience that has a span early through late is helpful.
• Leadership in providing integration of activities and delivering information across multifunctional groups and sites.
• Excellent interpersonal skills with the ability to adapt effectively to rapidly changing project strategies
• You can make difficult decisions in a timely fashion along with excellent follow through and organizational skills to assure team and organizational alignment
• You can influence partners without line authority
• Excellent communication skills, oral and written, as well as conflict management and negotiation skills
• This position is based in Beerse, Belgium and may require up to 15% international and domestic travel.

Responsibilities

• Implementing the Drug Product development strategy across all clinical phases including Life Cycle Management, through in depth understanding of the compound properties and TPP (Target Product Profile), aligned with PPDS functions, CMC team and CDT (Compound Development Team) who sets the overall compound strategy.
• Driving the project advancement in partnership with DPRD functions, CMC lead, CDT functions (preclinical and clinical) and the commercial organization while ensuring scientific standards are met
• Delivering clinical and commercial robust formulations and manufacturing processes, meeting manufacturing performance, cost needs, in line with QbD principles
• Representing DPRD as core member of the CMC team, with key interactions with API and analytical integrators, supply chain, Quality Assurance, CMC Regulatory Affairs and external consultants and vendors.
• Co-leading the BioPharm team, composed of CMC functions, clinical, preclinical, regulatory, non-clinical safety and/or other relevant functions to ensure correct formulation selection in view of the required PK profile, to determine bridging strategies, to define clinically relevant controls and ultimately accurate specifications.
• Responsible to have a full product and process technical/scientific understanding.
• Responsible for and driving the Governance Review for the assigned projects.
• Managing the DP risk register and defining mitigation plans and ensuring rapid identification and resolution of problems.

Skills

Leadership

Cross-functional collaboration

Scientific leadership

Communication

Problem solving

Project management

Education

Master's Degree

PhD

Job description

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.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Pharmaceutical Product R'D

Job Category:

Scientific/Technology

All Job Posting Locations:

Beerse, Antwerp, Belgium

Job Description:

There is already a pre-identified candidate for this position.

The Principal Scientist (ST7) Scientific Integrator leads a sub team of Drug Product research & Development (DPRD) scientists including Oral Solid Dosage Development, Parenterals & Liquids, Pharmaceutical and Material Sciences, Primary Container & Device, integrating DPRD activities so that deliverables are being met balancing cost/time/quality. Specifically, the Scientific Integrator (SI) will provide strategic and scientific technical leadership, ensuring the focus on scientific excellence is maintained within the DPRD/CMC teams.

Tasks & Responsibilities:

• This role will be focused on implementing the Drug Product development strategy across all clinical phases including Life Cycle Management, through in depth understanding of the compound properties and TPP (Target Product Profile), aligned with PPDS functions, CMC team and CDT (Compound Development Team) who sets the overall compound strategy.
• Driving the project advancement in partnership with DPRD functions, CMC lead, CDT functions (preclinical and clinical) and the commercial organization while ensuring scientific standards are met
• Delivering clinical and commercial robust formulations and manufacturing processes, meeting manufacturing performance, cost needs, in line with QbD principles
• Representing DPRD as core member of the CMC team, with key interactions with API and analytical integrators, supply chain, Quality Assurance, CMC Regulatory Affairs and external consultants and vendors.
• Co-leading the BioPharm team, composed of CMC functions, clinical, preclinical, regulatory, non-clinical safety and/or other relevant functions to ensure correct formulation selection in view of the required PK profile, to determine bridging strategies, to define clinically relevant controls and ultimately accurate specifications.
• Responsible to have a full product and process technical/scientific understanding.
• Responsible for and driving the Governance Review for the assigned projects.
• Managing the DP risk register and defining mitigation plans and ensuring rapid identification and resolution of problems.

Qualifications & Experience

• You have a Master's Degree or PhD in Chemistry, Pharmacy, Biochemical Engineering, Chemical Engineering or a related field with five to ten (5-10) years of experience or the equivalent training/experience
• You have competencies and experience in Drug Product development within the pharmaceutical industry. You demonstrate a high level of technical understanding.
• You have experience in scale up of manufacturing processes and technical transfer of projects into commercial manufacturing.
• Drug Product development experience that has a span early through late is helpful.
• You can demonstrate leadership in providing integration of activities and delivering information across multifunctional groups and sites.
• You have excellent interpersonal skills with the ability to adapt effectively to rapidly changing project strategies
• You can make difficult decisions in a timely fashion along with excellent follow through and organizational skills to assure team and organizational alignment
• You can influence partners without line authority
• You have excellent communication skills, oral and written, as well as conflict management and negotiation skills
• This position is based in Beerse, Belgium and may require up to 15% international and domestic travel.

Preferred Skills:

Budget Management, Chemistry, Manufacturing, and Control (CMC), Clinical Trial Protocols, Critical Thinking, Cross-Functional Collaboration, Drug Discovery Development, Industry Analysis, Interdisciplinary Work, Market Research, Organizing, Pharmacokinetic Modeling, Process Improvements, Product Development, Product Strategies, Report Writing, Safety-Oriented, Scientific Research

The anticipated base pay range for this position is:

€79.800,00 - €137.770,00

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees' and companies' performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location's eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.