Boehringer Ingelheim Head of 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.
The global Head Formulation Sciences provides operational leadership and direction for internal and external formulation development teams which are responsible for the global development of drug product from early stage drug product (DP) development up to and including hand-over to Late Stage Drug Product Development (LSDPD).
The mission statement of the formulation sciences function is to develop dosage forms in lab-scale to be used for the clinical development. These dosage forms need to be manufacturable and need to meet expected market demands.
The position holder needs to ensure that for this purpose a broad range of manufacturing technologies and the corresponding equipment, people structures and people are available in different lab areas globally, i.e. the position holder is responsible for formulation development laboratories at all sites globally. In addition this role drives the formulation sciences teams and the global formulation sciences leadership team to high performing teams. All different dosage forms (solids, liquids, parenteral, inhalative, topical, chewable, etc.) belong to the formulation sciences teams’ expertise.
Key responsibilities comprise pre-formulations, research and proof-of-concept formulation development, intended final formulation (iFF) and final formulation development according to Target Product Profiles (TPP) in laboratory and small pilot scale and handover to LSDPD.
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:
Participate as an active member of the global Pharmaceutical Science (PS) leadership circle, ensuring achievement of overall PS goals.
Proactively ensures alignment with other PS functions, e.g. analytical sciences, late stage drug product development (LSDPD) sciences, risk management, compliance and quality, computer systems and equipment PS and the site operations PS in Ingelheim and North Brunswick.
Responsible for pro-actively providing the head of PS and the 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.
Leadership, training, challenging and supervision of experienced laboratory heads and lab technicians globally; 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 techniques), budget (internal, subcontractors), and compliance (training, SOPs).
Defines and updates roles for team heads and their job profiles; safe-guards and updates the structure if needed.
Drug product (DP) develops ability assessment of New Chemical Entities for relevant milestone decisions and evaluation of in-licensing opportunities.
Ensures that team heads and teams are developing globally regulatory acceptable formulations and robust processes in lab scale for manufacturing clinical trial supplies in laboratory- and small pilot scale, including intended Final Formulation (iFF) development of all dosage forms for commercial purposes in lab scale and for transfer to LSDPD.
These dosage forms need to be manufacturable and need to meet expected market demands.
Responsible for authoring and review of major pharmaceutical submission documentation as well as provision of responses to authority questions.
Ensuring that the teams are documenting development activities to support submission and patent applications.
Ensures that team heads and teams 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 and quality risk management principles for early stage DP development to ensure state-of-the art science and risk based development approach.
Direct complex laboratory and manufacture investigation to ensure scientific validity of the investigation conclusion.
Proactively ensures regulatory, GxP and EHS compliance for all teams globally
Lead of or participation in strategic initiatives improving the Drug product development process.
Monitoring of LSDPD projects to optimize early stage drug product development/formulation development.
Ensures that team heads and team members can act as a Formulation Science representative in a technical development team of a pharma R&D project to provide optimum and effective Formulation Science support for pharma R&D activities and to ensure all Formulation Science activities met overall project time-line.
PhD (or equivalent) in the Life or Chemical Sciences or Pharmacy from an accredited institution required and with at least ten (1)0 years of relevant experience in pharmaceutical product development and management.
Ten or more (>10) years in-depth experience and expertise in formulation development of multiple dosage forms.
Excellent knowledge of Pharmaceutical development.
At least five to ten (5-10) years’ experience with leadership and management of direct reports
Ideally, more than one successful developed formulation on the market and multiple patents filed.
Strong management skills and capability in building efficient and effective formulation science teams.
Ideally, experience in global leadership role.
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.
Transparent in communication of failures.
Positive attitude and willingness to take risks.
Ability to challenge teams and team heads and able to recommend innovative alternatives.
Capability to deal with a variety of challenging matters including set-backs and failures.
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
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.
Title: Head of Formulation Sciences
Location: Americas-United States-NJ-North Brunswick
Requisition ID: 185242