Scientist IV, Analytical Development

Description
Designs and executes experiments to develop robust, scalable, transferable, analytical methods for biological active ingredients and final products. Develops and supports in-process testing for biological development and release tests for final products. Responsible for both technical and communication roles for his/her function on Research & Development (R&D) new biological project core teams. Provide early development guidance to Research projects. Identify and implement innovative technology for analytics.
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, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities
Initiates, designs, interprets accurately, troubleshoots and completes routine procedures independently and efficiently; initiates, designs, interprets accurately, troubleshoots and completes non-routine and difficult procedures without supervision; Initiates and conducts exploratory experiments
Develop, optimize, qualify, validate, and transfer analytical methods for characterization, in-process, release, and stability testing
Establish analytical control strategies for biological products and manufacturing processes
Present scientific data and recommendations to project teams and leadership
Provide technical guidance and training to junior scientists and laboratory personnel
Proposes, gains support for and implements ideas from individual’s knowledge of science and technology and understanding of drug discovery process
Proposes, evaluates and implements new technologies; independently applies basic scientific principles, performs literature searches, attends scientific meetings, and keeps abreast of literature in own field
Effectively communicates and defends own work, orally and in writing, in the context of the company and team goals at meetings
Demonstrates a contemporary level of technical proficiency in field; trains technicians and junior level scientists in this field
Reports and treats data with a high level of integrity and ethics
Complies with applicable regulations, performing all work in a safe manner; maintains proper records in accordance with Standard Operating Procedures (SOPs) and policies
Participate in cross departmental project teams when assigned
Understanding of USDA, EMA, VICH and applicable regulatory requirements for veterinary biological products. Collaborates across Research, Development, Clinical, Regulatory, Quality and Operations
Develop analytical control strategies appropriate for diverse biological product modalities throughout the product lifecycle
Support product characterization, process development, comparability assessments, technology transfers, and regulatory submissions
Apply modality-specific analytical approaches to assess identity, purity, potency, aggregation, molecular integrity, and stability
Serve as a technical subject matter expert for characterization strategies supporting novel and established vaccine and biologic platforms
Desired Skills, Experience, and Abilities
Demonstrated expertise in nucleic acid characterization, PCR, qPCR, RT-qPCR, digital PCR, sequencing-based technologies, nucleic acid extraction, quantitation, integrity assessment, and molecular assay development, qualification, validation, and transfer
Extensive experience developing, optimizing, qualifying, validating, and transferring analytical methods and establishing analytical control strategies for biologics and vaccines
Expertise with ELISA, Western Blot/Immunoblot, antigen quantification assays, antibody characterization assays, potency assays, and identity assays
Hands-on experience with SDS-PAGE, CE-SDS, densitometry, SEC-HPLC, aSEC, aCEX, and related chromatographic and electrophoretic methods
Demonstrated analytical development and characterization experience supporting biological product modalities
Requirements
PhD from an accredited institution with two (2) years of experience in a related scientific discipline; or Master’s Degree from an accredited institution with a minimum of six (6) years of experience in a related scientific discipline; or Bachelor’s Degree from an accredited institution with minimum of ten (10) years of experience in a related field
Research methodology experience and education
Advanced training in the area of technical expertise
Demonstrated knowledge of field
Expertise in the Biologicals/pharmaceutical life cycle process
Must have a thorough understanding of USDA and EMEA regulatory requirements
Demonstrated project management skills
Propose new experimental designs, Conduct probing experiments
Plan and conduct scientific/laboratory experiments and evaluate and interpret data
Provide training and guidance to laboratory personnel
Prepare technical reports, publications and oral presentations
Act as a leader in absence of supervisor
Appropriate level of understanding of applicable regulations
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
Our Company
Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.
Why Boehringer Ingelheim?
With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.
Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.
Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.
Want to learn more? Visit https://www.boehringer-ingelheim.com