BD (Becton, Dickinson and Company) Staff Scientist, Chemistry in Vernon Hills, Illinois
Job Description SummaryThe Staff Scientist provides chemistry support and/or remediation of drug products currently on the market as well as new drug products under development. The incumbent to the Staff Scientist position will have expert skills in pharmaceutical product development as well as experience in authoring CMC sections of regulatory submissions and generating written responses to regulatory agency questions.
The candidate must possess a deep understanding of the pharmaceutical development process throughout the drug product’s life-cycle to deepen collaboration with cross-functional teams seeking to develop new drug products in support of BD’s Infection Prevention product portfolio. The Staff Scientist is also expected to lead projects by applying scientific knowledge and skills within respective discipline as well as by creating experimental plans and coordinating the work of junior staff in support of various product development projects.
Pharmaceutical Development : Actively lead and participate in activities to support the development of novel pharmaceutical dosage forms for the Infection Prevention Platform. Conceive and develop technologies to advance business goals internally and through the identification of external collaborative opportunities. Deliver new product solutions which offer differentiating value to the business, our customers, patients, and the environment.
Regulatory Writing : Actively author and defend applicable CMC activities for products under development. In addition, provided written responses to regulatory agency questions for variations and new product submissions.
Technology Transfer : Work with in plant resources to implement and execute efficient and effective transitions of products from research & development to manufacturing.
Process Effectiveness : Utilization of the scientific method to identify problems or potential risks and deliver quick, effective solutions to enable projects to meet their timing and deliverables. Ensure appropriate processes are followed for effective and timely engagement of other parts of the company in product development activities.
Innovation : Create and promote an environment in which technical innovation can flourish through empowerment, encouragement, and support. Recognize and reward risk taking and rule changing solutions that enable business growth.
Continuous Learning : Actively seek training to improve skills. Ensure technical lessons are reviewed, learned and disseminated. Actively teach and promote and reward learning.
R&D Communication : Hold and encourage frequent formal and informal communication within the team.
Influence Others : Intuitively and quickly assess people and situations and act accordingly. Demonstrate strong persuasion and timing skills. Remain open to be persuaded when appropriate.
Inclusive Work Environment : Promote and leverage diversity to achieve best outcomes. Ensure all interested parties have opportunities to influence and contribute to decisions and outcomes.
Associate Development : Actively mentor associates in related technical roles. Provide technical direction and frequent feedback. Participate and assist in their success. Continue to raise the bar on technical skills and help associates rise to expectations.
Leadership Courage : Demonstrate and promote leadership courage by doing what is right. Engage those who disagree to persuade or be persuaded. Instill confidence in associates and customers. Demonstrate agility and taking appropriate action when facing change and uncertainty. Effectively manage change and instill confidence.
Demonstrates developed knowledge of respective scientific discipline and standard scientific method and techniques.
Applies knowledge and skills to a wide range of standard and non-standard situations.
Expert knowledge in product development in accordance with ICH and global pharmacopeia requirements (pre-formulation, process development, method development / validation, drug product characterization, and cGMP drug product manufacturing).
Knowledge of separations sciences (liquid chromatography, gas chromatography, solid and liquid phase extraction, purification, TLC).
Expert knowledge of basic wet chemistry techniques (pH, weighing, titrations) as well understanding of any applicable pharmaceutical/pharmacopeia requirements.
Understands market and customer needs and the related products.
Possesses a strong understanding of product development process, regulatory, and quality requirements pertaining to pharmaceutical product development.
Competent technical writing skills pertaining to the SOP development and drafting of technical reports based on a given targeted audience.
Captures, documents and communicates project related information from multiple sources.
Works in multidisciplinary teams and creates external partnerships; communicate results and needs to senior technical colleagues and suppliers.
Proficient with the use of statistical techniques as applicable to measurement system analysis, process validation, design of experiments and evaluation of stability data.
Possesses a strong mathematical and reasoning ability. Interprets a variety of instructions furnished in written, oral, diagram, or schedule form.
Defines problems, collect and interpret data, establish facts, draw valid scientific conclusions, and propose solutions or corrective actions.
Organizes and prioritizes own work with limited guidance and manages projects in a timely and effective manner. Ability to multi-task various activities.
Reorganizes and reschedules work on short notice in order to meet revised deadlines.
Works with colleagues and multiple clients in a professional and organized manner, and interact effectively with a variety of people from different nationalities, ethnic/cultural backgrounds, and educational levels.
Understanding of FDA requirements related to product development and chemical testing requirements for pharmaceutical products.
Understanding of GMP documentation requirements.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Familiarity and experience with authoring of Module 3 of CMC submissions. In addition, experience with authoring responses / justifications to regulatory agencies to support variations and new product submissions.
Ability to discuss scientific strategies/results and interact with other functional areas, including Regulatory, Manufacturing, and Quality.
Acts a resource for colleagues with less experience.
Education : PhD or MS/BS in Chemistry or Biochemistry/Pharmaceutics with related science experience.
Experience: Minimal of 7 years of demonstrated experience in the field of pharmaceutical analysis to include topical or liquid dosage forms, i.e. solutions, suspensions, emulsions, micro-emulsions, etc. is essential.
Possess demonstrated experience in working under an FDA regulated environment and has mastery of GMP documentation requirements.
Experience with validation of pharmaceutical product development per ICH guidance requirements.
Manage and direct project team, including identifying, directing, and delegating tasks necessary for successful project completion.Previous experience with interpretation of scientific results and writing scientific documents to support submissions in major global markets.Previous experience with writing scientific protocols and reports.Travel Expectation: Less than 10% of time.
Knowledge of the requirements for pharmaceutical products in major global markets (i.e. US, Europe).
Experience with medical devices (21CFR820) is helpful but not essential.
Primary Work LocationUSA IL - Vernon Hills
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.