Boehringer Ingelheim Fremont is the rapidly growing US arm of Boehringer Ingelheim's Biologics Business Unit. We are a fully integrated biologics operation with over 500 scientist and specialists, covering cutting edge early- to late stage CMC development, clinical and commercial drug substance and drug product manufacturing, medical device assembly for combination products and packaging operations.
We are continuing our rapid growth, investing over $200m into the expansion of our capacity and capabilities, and creating approximately 200 new jobs.
Driving this growth is an exciting pipeline of multiple Boehringer Ingelheim novel biologic entities (NBEs) and biosimilars, as well as, a growing diverse portfolio of therapeutics we develop and manufacture for other leading pharma and biotech companies. This includes multiple commercial product launches planned over the next couple of years, for which we can tap into Boehringer Ingelheim's unique experience of having brought 30 biologics to market globally.
Leveraging our diverse talent pool, we are also driving technology and innovation globally, through major investment and collaborations into next generation manufacturing platforms and technologies, which may change how biologics will be made in the future.
Whether we work on our own products, help partners to bring their products to market or innovate new technologies and approaches - Everything we do, we do to help patients!
This is a high-level staff Quality Control position, responsible for conducting microbial reporting and investigation requiring a higher level of expertise than the Senior Associate level. Incumbent exercises judgment within well-defined and established procedures and practices to determine appropriate action - identifies problems and generates alternatives and recommendations to resolve problems within defined guidelines. Incumbent coordinates and conducts reviews and investigations in situations involving deviations of product quality from governing procedures, processes and regulations. Incumbent is also responsible for reporting, reviewing and approving test results, trend reports and validation of methods. Incumbent leads coordination and communication between departments and across functions.
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:
Under minimal supervision, conducts lab investigations, problem-solving, provides supervision of microbial sampling/testing and reports aberrant results to management.
Follows well-defined and established procedures and best practices.
Reviews QC test results
Generates, reviews and/or maintains records or documents in a detailed and consistent manner.
Prepares sample reconciliation reports and other reports as needed.
Assists with QC's data management, including data review and control charting.
Coordinates and manages continuous improvement projects
Revises standard operating procedures, training manuals, business processes, and controlled documents which are submitted to superiors for adjustments and final approval.
Maintains specific QC files and database records for process and/or quality improvement efforts.
Manages and maintains Deviation and Change Control records.
Interacts with functional groups within and outside of QC and recognition of issues that require elevation to upper management.
Assists manufacturing area managers or designates with areas identified for trouble-shooting, for corrective actions related to quality investigations.
Provides technical expertise, execute established policies and supervise documentation of Test Methods and Specifications. Ensure updates are performed on time and documentation meets current regulatory guidelines.
Bachelor's degree from an accredited institution in Microbiology or a related field
At least nine to thirteen (9-13) years of experience demonstrating good knowledge of computer system validation, GMP and FDA, SUP and European regulations relating to material/product samples and testing.
Working knowledge of quality monitoring requirements and testing methods.
Ability to present data, investigations and laboratory processes to a larger audience (i.e. upper management, regulatory agencies, clients etc.).
Ability to author protocols, test methods, and SOPs.
Capability in conducting in-depth, complex investigations including an ability to articulate the investigation clearly in writing for submission to the Quality Control group.
Demonstrates proficient computer skills (i.e. documentation systems, databases and spreadsheets) and knowledge of Microsoft applications.
Demonstrates strong interpersonal and communication skills (both written and oral), a strong customer focus, and an ability to interact with various departments and levels.
Demonstrates ability to work independently and as part of a team, to meet departmental/facility goals; is also able to work across functions to achieve common goals.
Demonstrates strong attention to detail, and an ability to focus on details of execution.
Demonstrates ability to work effectively on problems of a diverse scope, with analysis/evaluation of data, using strong math skills.
Demonstrates good facilitation, organizational and problem solving skills, as well as demonstrated technical expertise.
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, 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.