Process Development Scientist
September 09, 2016

About the company
A career at the company offers opportunity, ownership and impact.

All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
This position will be part of Pharmaceutical Research and Development. The incumbent will participate in the development, scale-up and transfer of parenteral formulations and manufacturing processes for various biologics modalities such as monoclonal antibodies, antibody drug conjugates, proteins and vaccines. This is a laboratory based position performing formulation and process development activities for biologic products from pre-clinical and Ph I clinical trials through manufacturing process performance qualification, license application and commercialization.

The Senior Scientist, Biotherapeutics Pharmaceutical R&D (BTx PhRD), is a laboratory based position for performing formulation and manufacturing process development activities of therapeutic biologic drug products including prophylactic and therapeutic vaccines and therapeutic protein-based modalities ranging from pre-clinical and Ph I clinical trials through commercialization. The position will involve use of innovative and modern techniques to develop and characterize dosage forms with appropriate stability profiles and develop associated manufacturing processes to meet project needs. Data generated by the incumbent will be utilized to nominate dosage forms, support clinical trial applications, scale-up and enable transfer of manufacturing processes, and to support product licensure-related activities in accordance with ICH guidances Q8 and Q9. The incumbent will author written documentation and regulatory filings associated with his/her work, and will participate in technology transfer activities to manufacturing sites. The Senior Scientist, BTx PhRD, must be able to interact effectively with a multidisciplinary team of scientists and engineers for formulation and process optimization and overall product development. Effective communication skills are essential for interactions with laboratory scientists, project managers and colleagues from numerous functions, serving on multi-disciplinary project teams.

Educational Background

PhD. with 0-3 years, M.S. with 7+ years, or B.S. with more than 10 years of industrial experience in Chemical Engineering, Biochemical Engineering, Pharmacy, Pharmaceutics, Physical Chemistry, Biotechnology, or equivalent.

PhD. with 0-3 years, M.S. with 7+ years, or B.S. with more than 10 years of industrial experience in Chemical Engineering, Biochemical Engineering, Pharmacy, Pharmaceutics, Physical Chemistry, Biotechnology or equivalent. Experience in biologics or vaccines drug product development desired.

Work Experience/skills
Minimum: Newly qualified Ph.D. or 7+ years with M.S. or B.S with more than 10 years of industrial experience in formulation development, pharmaceutics, pharmacy, drug product process development, manufacturing, and scale-up.

Desirable: Knowledge of drug development processes for progression of a biological candidate.

Technical Skills
• Knowledge of heat and mass transfer of solids and fluids, materials science
• Skilled in programming languages and computational software
• Awareness of protein, vaccine and/or oligonucleotide chemistry, degradation pathways, and stabilization techniques
• Experience in biotherapeutic parenteral drug product formulation or process development of protein/peptide, vaccines or oligonucleotide therapeutics
• Excellent oral and written communication skills and ability to mentor junior staff and peers across matrix teams
• Leadership skills
• Knowledge of analytical and bio-analytical methods for biologics
• Experience in vaccine formulation and process development
• Experience in scale-up and technology transfer of aseptic processes to pilot/commercial scale manufacturing facilities
• Theoretical and practical knowledge of lyophilization and lyophilization cycle development
• Experience working with cells and virus
• Solid understanding of thermodynamics and kinetics
• Familiarity with GLP/GMP requirements
• Experience in authoring regulatory submissions (IND, IMPD, BLA, MAA)
• Experience in application of QbD concept in design, execution, and interpretation of formulation and process development experiments
• Knowledge of ICH Q8 and Q9 guidance
• Familiarity with Intellectual Property (IP)

Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.

EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
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