Senior Principal Specialist, QC Methods - REMOTE

Description:

Description\:

The REMOTE Senior Principal Specialist, QC Methods drives Quality Control process understanding and improvements by leveraging data assets (e.g. SAP, QC databases) and advanced analytical tools (e.g. SoftMax, Minitab, JMP) to help make data-based formulation decisions.  Contributes to improving data assets, develops tools for prototyping, and influences decisions on data-driven formulation strategies, and serves as a department Subject Matter Expert for assay data analysis.  Designs strategies for product formulation activities required to complete goals and milestones in Quality Control (QC) and Global Supply.  Analyzes and interprets experiments, studies, and data that have a new, novel design or use new technologies and, in addition, data from studies that follow established approaches.  Plays an influencing role as a Subject Matter Expert in his/her field in QC for project teams, across functions, and senior management.  Provides data analysis and continuously improves local and regional formulation processes and reference stability monitoring relevant to Global Supply with respect to Quality Control test methods and data while maintaining defined compliance levels. Works with senior leadership, process scientists, and production personnel to partner and develop strategies to monitor and optimize vaccine production processes.   Provides significant knowledge and has influence on go/no-go decisions within QC on product formulation strategies, experimental studies, projects, method optimizations, and reference qualification studies.  Possesses a knowledge of regulatory policies related to his/her function and fully understands their scientific basis.  Evaluates studies and reviews operations and QC protocols and reports.  The scope of the position extends from his/her function, site, multidisciplinary project teams, and across multiple functions.  Partners with PTS (Production Technology Support) for process improvements.

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 several 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\: 

• Develops an understanding of QC team goals and works effectively toward achieving them. Interacts with site Leaders.
• Analyzes complex biological processes and QC data and works to identify and prioritize analytical method problems and opportunities leading to more robust processes.  Determine sources of assay variation and propose improvements.
• Develops expertise in a specific project-relevant area or technology. May provide guidance and expertise to advance specific projects or evaluate and propose new technologies and concepts in support of multiple projects.
• Represent QC in strategy development, deployment of technical solutions for process optimization/improvement of all phases of vaccine production with the goals of improving process stability, yields, and cost of goods.
• Complies with all applicable regulations. Ensures that work performed in area of responsibility is conducted in a safe and compliant manner. Maintains proper records in accordance with Standard Operating Procedures (SOPs), GDP practices and policies.

Compensation\:  This position offers a base salary typically between $101,400 and $126,700. There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please  click here .

Requirements\:

• Bachelor's degree in relevant scientific or related field with a minimum of 8 years QC methods and/or processes or relevant scientific experience in a cGMP or similarly regulated environment.
• Or, Master's Degree and a minimum of 6 years QC methods and/or processes or relevant scientific experience in a cGMP or similarly regulated environment.
• Or, PHD and a minimum of 4 years QC methods and/or processes or relevant scientific experience in a cGMP or similarly regulated environment.
• Experience must be broad in analytical method data analysis and improvement.
• Advanced training in the areas of ELISA data analysis, analytical method validation, or formulation assessment. 
• Demonstrated knowledge of biochemistry and immunobiology with hands on experience analyzing ELISA potency data.
• Outstanding communication skills and experienced in project/program management.
• Must be proficient in Office software, including Microsoft Project, Excel, Word, and Power Point. Proficiency in advanced statistical and analytical tools (e.g. Minitab, JMP, SoftMax).

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.
• This position will require individuals to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation. Click  here  for more information on the vaccine mandate and COVID-19.

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   and join us in our effort to make more health.

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients, and communities. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.