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.