Works independently to provide analytical testing support for release, stability, validation, and in-process samples while adhering to current Good Manufacturing Practices (cGMPs). Utilizing a wealth of previous experience provides a high level of independent judgment and discretion in the timely identification, investigation and resolution of events impacting the Quality of products and processes. Responsibilities include support of analytical testing per approved SOPs and methods, analyzing and troubleshooting aberrant data, and maintaining audit readiness of laboratory. Must be able to identify and report aberrant results to manager and conduct or assist in laboratory investigations. Must be able to author analytical protocols and reports for method transfer and/or method validation. Individual must understand regulatory guidelines for analytical method validation and translate guidelines into effective experimental designs. Must be able to communicate experimental design to other analysts that would participate. Must be able to effectively multi-task with respect to analytical testing support, writing protocols/reports, and reviewing data.
With autonomy and authority, makes difficult decisions with little time for deliberation which may have a direct impact on active manufacturing operations, the release of equipment, and test results. Responsible for mentoring, coaching, may act as a delegate to sign official documentation in the place of management, regarding decision making processes and process expertise with high-level quality oversight to ensure compliance with cGMP’s, regulatory, industry, and corporate requirements. Implements continuous improvement efforts as it relates to QC activities. Indirectly leads others within the QC team under the leadership of the area head. Fosters quality collaboration among the site and QC staff.
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:
- Responsible for method validation and method transfer activities. Must understand ICH guidelines and translate requirements into effective experimental designs. Must be able to manage completion of entire method validation including the coordination of approvals for protocols/report, completion of experiments by other junior analysts, incorporation of comments into protocols/report, and overall completion to agreed timelines and ensuring communication/escalation of potential issues of broader impact to the business.
- Actively support cross functional teams and share information, able to initiate and effectively conduct cross-functional meetings as appropriate, with colleagues.
- Responsible for both executing the tactical operations and overseeing junior team members executing testing. Under no supervision leads/participates in analytical laboratory investigations, solve technical problems such as invalid assays or equipment breakdown, and identify aberrant results to management. Follows well-defined and established procedures and best practices. Reviews and approves QC test results in a timely manner.
- Performs independent technical review of documentation during and post-execution of cGMP activities. Has authority to sign off/qualify/train junior staff on QC responsibilities. Ensures all specifications, assay and system suitability are met and that applicable requirements are completed and acceptable. Ensures all issues/documentation associated with each process in assigned area have been resolved and approved are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures. Analyzes and reports findings to appropriate departments.
- Identifies and resolves critical issues (including deviations, investigations, OOS, etc.), as appropriate and typically works on complex Major issues. Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone. Works closely with others to determine root cause and potential preventative/corrective actions. Ensures support for the timely closure of investigations.
- Must be able to pro-actively identify issues to prevent missed timelines.
- Independently serves as QC representative in decision making and conflict resolution with junior team members as needed in the absence of the department head.
- Authorized to inhibit the release of test results when the situation warrants. Provides guidance and control directives regarding remediation activities required to continue testing. Is required to resolve critical issues utilizing independent judgment and decision making as a senior level of the department. May serve as the final decision-maker in situations requiring the Sr. QC Specialist utilizing the input of others to make a final compliance determination.
- Highly productive, attention to detail, ability to manage own time and time of junior staff to prioritize tasks independently and meet timelines. Maintain laboratory to a high quality and compliance standard. Provide supervisory role to ensure testing result is released on time in Manager's absence.
- Effectively communicate with supervisors, colleagues and/or managers in other departments and sites. Sought after by junior team members for guidance on method validation, transfer, qualification.
- Works closely with others in the assigned area to recognize opportunities for improvement and drive change through the use of BIFI’s Quality Systems. May be asked to become a certified Green-Belt and be assigned to lead process improvement initiatives via the BPE program. May also attend, as a QC project team member to provide QC guidance and oversight to such improvements.
- Provides guidance to MFG, E&T, and/or QA to ensure compliance with all applicable regulations and assists in resolution of issues identified. Information must be pro-actively shared across QC and the business including the on-going training of junior team members. Must be able to interact effectively with other groups to provide support, review of data, sharing of information/scheduling.
- Will serve as Subject Matter Expert for internal or external matters. Participates in inspection readiness activities and significantly involved in inspections by regulatory agencies.
- Models effective and constructive communication behaviors and interactions with technical departments, junior team members and senior business leaders, both orally and in writing; maintain acceptable proficiency in technical and non-technical (e.g. interpersonal) skills.
- Is proficient in technical and non-technical (e.g. interpersonal) skills to ensure the continued success of the department and quality control provided to the business.
- Creates and establishes processes and procedures to ensure compliance and adherence to regulated QC activities for cGMP operations.
- Mentors, trains and coaches new personnel as required and supports the development and implementation of training programs. Available to act as a resource for colleagues with less experience regardless of the level. Will provide input on the performance of junior team members to the department head as part of the performance management process.
- Requires a Bachelor’s Degree in Biochemistry, Chemistry, Microbiology, Molecular and Cellular Biology, or Biology (or closely related degree with these core courses as the foundation) with eight (8) years of experience OR Master's Degree with four (4) to six (6) years of experience OR PhD with one (1) to three (3) years preferred.
- Quality control experience in the pharmaceutical industry providing guidance to Manufacturing Operations, QA, and other cGMP areas.
- Direct experience is required in method qualification, method transfer, and method validation in accordance with ICH guidelines[SZ1] .
- Strong technical writing skills
- SME in Analytical methods such as Bioassay, ELISA, or Biacore technology
- Knowledge of and the ability to implement CFR, USP, and ICH requirements
- Ability to implement testing in accordance with 21CFR11
- Advanced knowledge of relevant regulations and guidances in order to act as a resource for colleagues.
- Proven project management skills. Possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
- Possess excellent verbal and written communication skills; good interpersonal skills.
- Possess strong conflict resolution and negotiation skills
- Independently represent the department in a wide-assortment of situations
- Emerging leadership and mentoring experience. Must be able to indirectly lead others at the bench in the absence of the department head.
- Experience leading people and/or projects with history of achieving results and outstanding outcomes
- Strong independent judgment and decision making abilities required
- Independent decision making capability and ability to think conceptually and understand impact of decisions critical.
- Physical Demands / Surroundings - The duties of this position may require the incumbent to exert some physical effort. Weight is typically no more than 25 pounds. .
- Visual Demands - Must be able to read and see clearly.
- Temperaments/Mental Requirements - Frequently required to exercise judgment and make decisions. Probable errors might cause moderately serious delays, confusion, and could affect company reputation/customer relations or expense to correct.
- Attendance / Schedule - Attendance requirements are based on BIFI general attendance policies.
Desired Experience, Skills and Abilities:
- Experience in method development
- Knowledge of LIMS
- Experience in equipment validation
- Direct experience in participating and supporting regulatory inspections through explanations of methodologies, investigations, and/or laboratory systems.
- Capability to establish good relationships with others who have different values, cultural styles and perspectives. Setting high and ambitious goals and standards for oneself and others, continuously raises the bar.
- Must be legally authorized to work in the United States without restriction.
- Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
- Must be willing to take a drug test and post-offer physical (if required)
- Must be 18 years of age or older