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US_Scientist III, Formulation Pharmaceutics

Company: Boehringer Ingelheim
Location: North Brunswick
Posted on: June 24, 2022

Job Description:

Description:Description\:
The Scientist III, Formulation will perform research and project support for the teams that are responsible drug product development, spanning pre-formulation to late stage scale-up activities without supervision.
The Formulation Development group supports programs across all stages of research and development providing technical leadership for the formulation and clinical drug manufacturing. Additionally, Formulation Development provides technical support for scale-up, technology transfer, product line extensions, intellectual property competitive assessments, and post-launch activities.
The Scientist III will be responsible for leading and participating in the research activities and project support for the Formulation Development group within the larger Development organization. The incumbent will be a Pharmaceutical Scientist (or equivalent) with expertise in the research and selection of formulations, dosage forms, and technologies to create new and innovative drug products. The position will also require a breadth of expertise in early, fit-for-purpose pre-formulation development with an understanding of Quality by Design to guide formulations through the transfer and scale-up of manufacturable formulations. The position requires excellent communication and leadership skills, and will require the incumbent to develop and maintain a successful network of internal stakeholders in the support of non-GMP and GMP development activities.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities\:

  • Perform research activities related to formulation, technology and drug product design/development; spanning preformulation to late stage development.
  • Partner with internal and external team members/collaborators to advance innovative and groundbreaking formulations and technologies
  • Proactively ensure alignment with other Development functions (analytical, late stage, risk-management) locally.
  • Provide leadership, training, and mentorship of direct/indirect reports and peers rooted in a strong understanding of pharmaceutical science principles
  • Contribute to the building of a learning organization and enhance the functional excellence of Formulation Development through leading scientific discussions, presentations at local/global meetings, and driving the overall science.
  • Drug product (DP) developability assessment of New Chemical Entities (NCE) and due diligence activities for relevant milestone decisions and evaluation of in-licensing opportunities.
  • Responsible for authoring and review of major pharmaceutical submission documentation and queries.
  • Review and approve protocols, reports, memos, specifications, CMC analytical sections, response to authorities, and other documentation that are scientifically valid.
  • Lead efforts to continuously refine the formulation development approaches by application of quality by design (QbD) and quality risk management principles throughout DP development to ensure state-of-the art science and risk based development approach.
  • Lead laboratory and manufacturing investigations to ensure scientific validity of the investigation conclusion.
  • Proactively ensures regulatory, GMP (when appropriate) and EHS compliance for all teams locally.
  • Lead strategic initiatives improving the Drug product development process.
  • Responsible for authoring publications, posters, presentations on research formulation activities.
  • Represent Formulation Development on CMC-Technical Development Team and ensure with management that Formulation activities are completed and meet overall project time-line goals and objectives.
    Requirements\:
    • Bachelors' degree from an accredited institution in a relevant scientific discipline required such as Pharmaceutical Sciences or Chemistry, plus five to eight (5-8) years of relevant experience preferred; or MS from an accredited institution in a relevant scientific discipline, relevant industry plus four (4) years of relevant experience preferred; or PhD from an accredited institution in a relevant scientific discipline, relevant experience preferred.
    • Minimum of four-plus (4+) years of in-depth experience and expertise in formulation development of multiple dosage forms.
    • Excellent knowledge of Pharmaceutical development.
    • Experience within a global, cross-functional setting with frequent interaction with both internal and external stakeholders relevant to formulation development.
    • Strong management skills and demonstrated capability in building efficient and effective formulation science teams.
    • Participation on local and global multi-disciplinary teams.
    • Willingness to take risks and perform ground breaking research.
    • Strong interpersonal skills and communication skills.
    • Operational and strategic thinking, skilled in negotiation.
    • Achievement focused with appropriate alignment for regulatory and quality requirements.
    • Decision making skills are critical with the ability to solve problems with speed to change.
    • Capability to deal with a variety of challenging matters including set-backs and failures.
    • Transparent communication, especially of risks, failures and learnings.
    • Positive attitude and willingness to teach others.
      Eligibility Requirements\:
      • Must be legally authorized to work in the United States without restriction.
      • Must be willing to take a drug test and post-offer physical (if required).
      • Must be 18 years of age or older.
        Who We Are\:
        At Boehringer Ingelheim we create value through innovation with one clear goal\: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

Keywords: Boehringer Ingelheim, Trenton , US_Scientist III, Formulation Pharmaceutics, Other , North Brunswick, New Jersey

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