Senior Manager, QC Biochemistry (m/f/d)
- Coordinates day-to-day operations within lab to ensure materials and products are tested, reviewed and approved within the accepted time frames. Interprets data and resolves technical issues for group. Ensures scientific and compliance based suitability of analytical methods used for testing materials and products through method transfers and method validations. Ensures compliance with current regulations.
- Primary contact (Reviews, authors, and edits) accountable for documents including; deviations, change control requests, SOPs, test methods, analytical investigations, and laboratory test plans and related technical reports. Ensures compliance with current regulations. Has excellent writing skills.
- Coaches, mentors, leads and supervises departmental scientists and managers. Ensures that training and other personal development programs are in place for succession planning and the development of subordinates. Ensures that performance opportunities are proactively managed through the Performance Management system.
- Motivates and develops employees, optimizes productivity and quality of work. Implements new strategies to streamline workload and increase sample throughput.
- Fosters an innovative environment/culture that is aligned to functional and organizational goals.
- Scientific lead responsible for investigations (within group) related to OOS, unexpected results, or invalids are performed appropriately and within expected timeframes. Ensures investigations are appropriately thorough to identify root causes or potential root causes and prevent recurrence.
- Represents QC Biochemistry in different decision-making bodies and meetings for Biosimilars, NBEs, and CMBs.
- Actively participates on multiple cross functional teams (may include facilitation) and share information, as appropriate, with direct reports. Effectively communicates with supervisors, process engineers, and/or managers in other departments and sites.
- Implements procedures and optimal infrastructure to ensure compliance with all regulatory agencies. Serves as the group representative on regulatory audits. Provides accurate and timely delivery of data and reports to support regulatory filings.
- Expert in method development, qualification, transfer and validation. Author and reviews method transfer/qualification/validation protocols to ensure acceptance criteria are appropriately set, experimental design is fit for use, and scope is accurately defined. Applies DOE or factorial design concepts to method validation.
- Leads local and global teams in cross functional initiatives (such as BI Chrom, BiPharm Global SOPs, Deviations, Transfer strategies)to drive business competitiveness and build value.
- Evaluates and implements new technology and methodologies to increase quality, compliance and productivity.
- Requires a minimum of a Bachelor's degree from an accredited institution with ten to twelve (10-12) years relevant biochemistry experience; or a Master's degree from an accredited institution with eight to ten (8-10) years experience; or a PhD from an accredited institution with at least two (2) years experience. PhD from an accredited institution plus more than five (5) years experience is highly preferred.
- A minimum of two (2) years of management experience is required; at least three (3) years of management experience is highly preferred.
- One to three (1-3) years experience leading projects
- Requires a minimum of eight (8) years in a laboratory environment with direct experience in bio-analytical techniques and equipment related to the testing of biotechnological products or chemicals (HPLC; CE; PCR; Bioassay; Immunoassays/ELISA; Physico-Chemical Techniques including UV/FTIR Spectroscopy, pH, Osmolality, Turbidity, Appearance, Sub-Visible Particles; and Wet Chemistry Techniques)
- GMP experience preferred, but exceptional candidates without GMP experience will be considered
- Experience in method development desired. Expert in method qualification, method transfer, and method validation required.
- Thorough understanding of biopharmaceutical process development
- Knowledge of CFR, USP, and ICH required.
- Knowledge of DOE and factorial design as applied to method validation desired
- Knowledge of Trackwise, LIMS, and Waters Empower Chromatography Data System desired.
- Ability to develop and manage budget plans and forecasts.
- Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff with a minimum of one to three (1-3) years in a leadership position preferred.
- Physical Demands / Surroundings - Works in an office or lab setting under desirable conditions with few or no disagreeable features. Duties do not require incumbent to exert physical effort beyond normal office / lab conditions. The individual may be required to enter and perform work in the laboratory areas. This may include periods of frequent standing or working at the bench. Some domestic and international travel required.
- Visual Demands - Must be able to read and see clearly. Vision clarity with or without correction to read handwritten as well as computer generated documents.
- Attendance / Schedule - Attendance requirements are based on general attendance policies and the needs of the business as set forth by direct manager.
Boehringer Ingelheim Pharma GmbH & Co. KG
Fremont, Californien [USA]
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