Associate Director, CMC Project Leader - Fremont, CA | Biospace
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Associate Director, CMC Project Leader

Boehringer Ingelheim Fremont, Inc

Fremont, CA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biotechnology, Manufacturing, Pharmaceutical, Process, Project, Project Management, Project Manager,

Job Description

The Associate Director, CMC Project Leader is responsible for leading the CMC development of complex biopharmaceutical projects. The main task of this position is to provide leadership and guidance to a global team of subject matter experts across various disciplines/functions. An in-depth understanding of drug development processes is required to enable the candidate to provide technical oversight of cross-functional activities within the assigned projects in order to bring about the successful development, manufacturing and launch of critical products. Using project management tools, the position will perform planning, controlling, monitoring and reporting for assigned projects. As this position is a key interface with internal and external clients and senior leadership, strong communication is required.

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:

* Leads the project team ensuring appropriate flow of information within the team/matrix organization.
* Responsible for setting and achieving project goals, including timelines, budget, and scope. * Defines work packages according to project scope (what and when).
* Defines and requests required resources at the responsible decision committees. Requests team members from line management.
* Prepares and conducts project team meetings including issuing of agenda, action items, and meeting minutes.
* Identifies, mitigates and if necessary, escalates project risks (quality, timeline, budget, scope).
* Prepares management decisions and communicates project updates to the relevant steering committee.
* Responsible for updates of the project plan and for preparation of additional or modified work packages and for initiation of corresponding updated offers to the clients.
* Represents the project team in Biopharma steering committees, BI committees and external client meetings.
* Maintains project documentation (project charter, project reports etc). Initiates and monitors the generation of regulatory documents by the CMC DRA representative and relevant team members.
* Ensures formal project closure (best practice identification, lessons learned, documentation).
* Supports CMB with verification of final proposal and contract. Acts as the primary contact person regarding the specific project for the clients or BI R&D team leader and international project manager and coordinates the flow of information from and to the client. Organizes and conducts meetings with external clients, including agenda, meeting notes, action items, and follow-up of action items. Understands and influences client’s expectations.



* Bachelors’ degree in a technical/scientific field required. Masters or PhD degree in Biopharmaceuticals is preferred.
* 7+ years’ industry experience (Biopharmaceutical, Pharmaceutical, Biotech) specifically with knowledge in Process Development, Process Transfer, Manufacturing Science or Process Science or equivalent experience in related industry.
* 1 - 3 years’ experience leading employees (direct or indirect reporting structure) and projects in relevant industry.
* International exposure in daily business is required.
* Able to illustrate complex issues and to evaluate them critically as well as to navigate a goal-orientated decision process.
* Possesses planning, organizational and communications skills.
* Able to professionally prepare presentations and present data to Biopharma steering committees, BI committees and external clients.
* Able to prepare and drive decisions within the team with committees and customers.
* Able to manage a number of projects simultaneously.
* Has experience in multicultural environments.

Desired Experience, Skills and Abilities:

* Possesses strong know how in the area of developing and manufacturing biopharmaceuticals.
* Has professional experience in managing projects.
* Adequately trained on the BI project management systems prior to leading a project team.
* Has extensive knowledge of organizational structures within biopharmaceuticals including steering committees and decision-making processes.
* Knowledgeable about interdisciplinary processes.

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 a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. 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. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Vetmedica Inc., Boehringer Ingelheim Fremont Inc., is an equal opportunity employer. M/F/D/V

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.