Boehringer Ingelheim Associate Director, Formulation Sciences in NORTH BRUNSWICK, New Jersey

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.

Description:

The Associate Director Formulation Sciences-North Brunswick provides operational leadership and direction for internal formulation development teams that are responsible for the activities related to drug product development, spanning pre-formulation through drug product development.

The Formulation Sciences (FS) group supports programs across all stages of research and development providing technical leadership towards formulation and clinical drug product manufacturing. Additionally, FS provides technical support for scale-up technology transfer, product line extension, intellectual property (IP) competitive assessments, and post launch activities for drug products.

Responsible for leading the local FS group within Pharmaceutical Sciences (PS), the FS group will be accountable for all formulation development activities related to the drug product, from pre-formulation and characterization to the development of scalable drug product formulations. The incumbent will be a Pharmaceutical Scientist with expertise for the selection of formulations and dosage forms, with significant experience in fit-for-purpose to robust and scalable formulation development. Additionally, the Associate Director will be responsible for maintaining a successful network with both internal and external stakeholders, and will provide technical support towards non-GMP and GMP operations.

Dedicated Pharmaceutical Scientist with proven history of building/growing teams and changing company culture. Long hours will be spent teaching and mentoring, demonstrating the principles of pharmaceutical science and formulation design to teams and team members. Positive attitude, strength of convictions, and ability to navigate challenging times a must. Honor and recognition in case of success.

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:

  • Lead the North Brunswick Formulation Sciences team for all activities related to drug product development, from pre-formulation to late stage drug product development

  • Participate as an active member of the local Pharmaceutical Science (PS) leadership team, ensuring achievement of overall PS goals

  • Pro-actively ensures alignment with other PS functions, e.g. analytical sciences, late stage drug product development, risk management) in North Brunswick

  • Responsible for pro-actively providing the head of FS and the larger PS leadership team with regular updates regarding the contemporary competitiveness of the formulation development teams and compliance with appropriate legislation

  • Management of operational procedures within area of responsibility

  • Provide leadership, training, and supervision of experienced teams and team members locally; selection of individual training measures and facilitation of best practice sharing

  • Maintain and enhance the functional excellence of Formulation Sciences in relation to people (organization design, recruitment, performance management, and safety), laboratory (design, maintenance, new instrumentation, supplies, new technologies), budget (internal, subcontractors), and compliance (training, SOPs)

  • Defines and updates roles for team members and their job profiles; safe-guards and updates the structure if needed

  • Drug product (DP) develop assessment of New Chemical Entities (NCE) for relevant milestone decisions and evaluation of in-licensing opportunities

  • Ensures that teams and team members are developing global regulatory acceptable formulations and robust processes in lab scale for manufacturing clinical trial supplies in laboratory and pilot scale, these dosage forms need to be manufactured and need to meet expected market demands

  • Responsible for authoring and review of major pharmaceutical submission documentation and queries

  • Ensuring that the teams are documenting development activities to support submission and patent applications

  • Responsible for authoring and review of major pharmaceutical submission documentation and queries

  • Ensuring that the teams are documenting development activities to support submission and patent applications

  • Ensures that team members are able to review and approve protocols, reports, memos, specifications, CMC analytical sections, response to authorities, and other documentation so that these documents are scientifically valid

  • Ensures that team members are able to review and approve protocols, reports, memos, specifications, CMC analytical sections, response to authorities, and other documentation so that these documents are scientifically valid

  • Continuous refinement of 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

  • Direct complex 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

  • Monitoring of FS projects to optimize early stage drug product development/formulation development

  • Ensures that team members can act Formulation Science representative in a technical development team of a Pharma R&D project team

  • Provide optimum and effective Formulation Science support for Pharma R&D activities

  • Ensure all Formulation Science activities met overall project time-line goals and objectives

  • Manages the local activities and interactions that impact FS and other R&D functions.

  • Need to be compliant with legislative expectations of regulatory agencies as well as the BI Quality Organization

  • Formulation Science will develop ground breaking formulations that are innovative and new

  • Manage and maintain a state of the art laboratory

  • Leads a team of 5 to 8 direct reports locally and interacts within the global FS team and larger Pharmaceutical Sciences department. Collaborate with multiple internal and external functions and partners in multiple countries

  • Key interfaces: LSDPD Sciences, Analytical R&D, Research, Technical Development Leaders, Operations, Risk Management Sciences, Compliance and Quality, Clinical Trial Supply, Clinical Functions (e.g. PKDM, Clinical Operations), external contract resource organizations and companies for due diligence, licensing evaluations, and formulation development

Requirements:

  • PhD (or equivalent) in the Life or Chemical Sciences or Pharmacy and with at least 6+ years of relevant experience in pharmaceutical product development and management.

  • Minimum of 6+ years’ in-depth experience and expertise in formulation development of multiple dosage forms

  • Excellent knowledge of Pharmaceutical development

  • At least 4-6 years’ experience with leadership and management of direct reports

  • Must be an experienced leader in 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

  • Leadership of global and multi-disciplinary teams and direct reports

  • Strong interpersonal skills and communication skills

  • Operational and strategic thinking

  • Skilled in conflict resolution and negotiation

  • Achievement focused with appropriate alignment for regulatory and quality requirements.

  • Willingness to travel internationally

  • Decision making skills are critical with the ability to solve problems with speed to change.

  • Ability to act as or to support team heads and team members to become internal key-opinion leader

  • 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 take risks

  • Ability to challenge teams and team heads and able to recommend innovative alternatives

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

Our Culture:

Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighborhoods where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.

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Organization: US-Vetmedica

Title: Associate Director, Formulation Sciences

Location: Americas-US-NJ-North Brunswick

Requisition ID: 1815413