Boehringer Ingelheim Duluth , GA 30198
The Technical Development Leader (TDL) is responsible for driving the development of and implementing a scientifically sound technical strategy for pharmaceutical new product development projects from late research through launch (stages R3- D4) as the leader of Technical Development Teams.
The Technical Development Team is a sub-team of the Core Project Team (CT) with delegated responsibilities in the areas of Analytical, Formulations, Process, Regulatory CMC, Packaging and Operations.
The Technical Development Leader must work globally and cross-functionally to manage the technical development portion of assigned projects to ensure the development of a robust technical documentation package and final product that can be registered with relevant health authorities and successfully industrialized.
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:
Formulate a scientifically sound and business driven technical strategy, in line with overall project strategy, involving Research Leader (RL), Global Development Leader (GDL), departmental project leaders and functional experts (as appropriate).
Lead multi-disciplinary global teams in line with Boehringer Ingelheim values and behaviors.
Build strong team spirit and promote knowledge exchange within and between teams. Ensure smooth operation and cross-functional alignment.
Implement and manage the technical development strategic plan for assigned projects (internal or external) following the Pharmaceutical Development Guide, Technology Transfer Process and other required guidelines/procedures.
Ensure all critical project milestones are met while maintaining a high level of quality.
Proactive communication of overall project strategy, key issues/risk and any other critical topics in a timely manner to the Technical Development Team (TDT), appropriate management level (i.e. RL, GDL and line management) and relevant stakeholders.
Drives the identification of strategic risks related to the technical development plan, regularly conduct risk assessments, and ensures development of mitigation strategies and contingency options.
Prepare and present information related to the technical development aspects, as requested, at internal governance meetings and external health authority meetings.
Manage the relationship between R&D and Operations in order to ensure a smooth hand-over of assigned projects as they move from development to industrialization.
Ph.D. in Science from an accredited institution required with five plus (5 ) years of pharmaceutical drug product development experience or- M.S. in Science from an accredited institution required with eight plus (8 ) years of pharmaceutical drug product development experience or- B.S. in Science from an accredited institution required with ten plus (10 ) years of pharmaceutical drug product development experience
Position requires significant experience in pharmaceutical drug product development.
Technical understanding of process development and good technical problem solving skills.
Experience interacting with commercial manufacturing organizations.
Good organizational skills and familiarity with developing drug product development timelines.
Familiarity with EMA and FDA regulatory requirements for new drug product submissions, ideally animal health related experience.
Leadership of global, multi-disciplinary teams involving the ability to lead without authority.
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.
Strong decision making skills with the ability to solve problems.
Transparent in communication of failures.
Positive attitude and willingness to take risks.
Ability to challenge teams and functional 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 neighbourhoods 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.