SR AD, QC Biochemistry/Chemistry
Responsible for ensuring that the Quality Control Biochemistry or Chemistry and Physico-Chemical Department provides appropriate oversight over biopharma clinical and commercial GMP operations to ensure that products are tested to comply with the requirements of regulatory filings and do not place patients at risk due to inadequate safety, quality or efficacy. Provide direction to members of the Quality Control Laboratories performing analytical testing of raw materials, in-process products, or final products pre-release based upon sound scientific practice and general laboratory and company policies.
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:
- Coordinate operations within lab to ensure materials and products are tested, reviewed and approved within the accepted time frames. Interprets data, identifies adverse trends, and provides strategic resolution to technical issues with group. Ensures scientific and compliance based suitability of analytical methods used for testing materials and products through method transfers and method validations. Ensure compliance with current regulations.
- Review, author, and edit documents, including deviations, change control requests, SOPs, test methods, analytical investigations, and laboratory test plans and related technical reports. Ensure compliance with current regulations.
- Coach, mentor, lead and manage departmental employees. Ensure that training and other personal development programs are in place for succession planning and the development of subordinates. Ensure that performance opportunities are proactively managed through the Performance Management system.
- Provide leadership for managers and analysts to optimize productivity and quality of work. Provide effective planning for QC Labs to include required resources, and the maintenance & communication of cycle times.
- Ensures investigations related to OOS, unexpected results, or invalids are performed appropriately and within expected timeframes. Ensure investigations are appropriately thorough to identify root causes or potential root causes and prevent recurrence.
- Bachelors or Master's degree from an accredited institution in Chemistry, Biochemistry or Biology
- Ten (10) years working in a laboratory environment with direct experience in bio-analytical techniques and equipment related to the testing of biotechnological products or chemicals working in a cGMP environment. Eight (8) years of relevant experience with a Master's Degree.
- Eight (8) years of leadership experience is required to lead multiple testing sub-groups (Biochemistry or Chemistry/Physico-chemical) to provide testing efficiencies while in full compliance with regulatory requirements. Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff is required. Six (6) years of leadership experience with a Master's Degree.
- Experience in leading analytical investigations for Out of Specification or Out of Trend Results in accordance with regulatory guidelines
- Experience in method development is desired. Direct experience in method qualification, method transfer, and method validation is required. Proven ability to influence strategic experimental designs that maximize efficiency in full compliance with regulatory requirements. Proven ability to manage simultaneous method qualifications, validations, or transfers in accordance with timelines and full compliance with regulatory requirements.
- Direct experience in participating and supporting regulatory inspections is required. Proven ability in leading laboratory tours, explaining laboratory systems, explaining methodologies, deviations, and/or issues to inspectors is highly desired.
- Proven ability to participate, influence and/or lead cross-functional projects (method transfers, system implementation, and technical transfer projects) between clients, BI sites, and/or BIFI departments is highly desired.
- Knowledge of CFR, USP, EP, JP and ICH is required.
- Proven ability to interpret 21 CFR11 and implement these requirements into process streams within the QC Chemistry organization is required. Proven ability to defend compliance of electronic records to regulatory or other inspectional representatives is required.
- Ability to develop and manage budget plans and forecasts.
- Excellent analytical skills with the ability to interpret data, identifies adverse trends, and provides strategic resolution to technical issues.
- Strong expertise in scientific and compliance based suitability of analytical methods used for testing materials and products through method transfers and method validations.
- Extensive experience writing stability reports, deviations, change control requests and lab test plans; reviews of Sops; technical reports and development of laboratory systems that are in accordance with current regulations.
- Effective leadership skills of managing staff in analytical investigations, monitoring of methods, and method/equipment troubleshooting.
- At least ten (10) to fifteen (15) years in a laboratory environment with direct experience in bio-analytical techniques and equipment related to the testing of biotechnological products or chemicals
- Eight (8) years leadership experience is required to lead multiple Biochemical or chemical testing sub-groups to provide testing efficiently and in full compliance with regulatory requirements. Proven ability is required to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff.
- Expertise is required in analytical techniques including HPLC, CE, PCR, Bioassay, and ELISA. Must be able to provide effective leadership to staff in analytical investigations, monitoring of methods, and method/equipment troubleshooting.
- Ten (10) years’ experience with cGMP required. Experience is required in leading analytical investigations for Out of Specification or Out of Trend Results in accordance with regulatory guidelines.
- Expertise is required in analytical techniques including Physico-Chemical assays (including UV/FTIR Spectroscopy, pH, Osmolality, Turbidity, Appearance, Sub-Visible Particles), and Wet Chemistry techniques.
- Expert in analytical testing of raw materials, in-process products, or final products pre-release.
- Highly regulated (FDA, DEA, EMEA, and EPA). Significant technical/operational risk due to increasing legal and regulatory complexity.
- The combination of intense regulation (i.e., pharmaceutical production, controlled substances, environmental and safety, etc.), overall risk of operations, and a dynamic process driven production environment results; in a complex business/operational model with multiple competing factors needing to be balanced.
- Coordination and communication between multiple departments, including manufacturing, process science and maintenance.
- Oversight of quality documents requires a high level of technical and regulatory knowledge and organization
- Work is primarily directed at the site; however, interaction with colleagues at other USA and worldwide sites is frequent
- Decisions directly affect the supply of clinical and commercial products and therefore have an impact to the overall success of the organization
- Effectiveness of quality function assures no interruption of product supply due to regulatory nonconformance.
Desired Skills, Experience and Abilities:
- Experience in trending analytical data (method and product) is highly preferred.
- 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, 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.