The Scientist II position will perform research and development support with minimum supervision as part of the biologic Formulation Development team. The Formulation group is responsible for preformulation of new biologics products through late stage product development. The incumbent will be a Formulation Scientist with experience supporting blending, evaluation of technologies, product characterization, stability, and transfer of new technologies for new biological products. Performs the below duties within Formulation Development with minimum supervision:

• Responsible to to assist in the initiation and completion of customary procedures via current documentation guidelines in transition of new ID projects to Operations in an efficient manner.
• Responsible to provide assistance in development, optimization, repeatability, and validation of formulation processes to prepare for qualifying or pre-licensing serials.
• Responsible to Communicate work orally, in writing and in presentation format by treating reports and data with a high level of integrity and ethics and can complete roles and responsibilities as a member of subteams.
Assist in studies to improve consistency and stability across modalities for new product formulations.

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

• Performs research and development studies related to biologics formulation, technology and final product design/development; spanning preformulation to late stage development and assistance in formulation technology transfer.
• Proactively ensure alignment with other local Development functions.
• Write formulation study protocols, seeks input from internal experts and literature, and authors study reports. Treats all data with a high level of accuracy, integrity and ethics.
• Assist in optimization efforts for current active ingredients and New Biological Entities (NBE) such as vaccines, proteins, antibodies, etc.
• Responsibilities include: Evaluation of different blending or stabilization technologies, product characterization, new equipment and/or parameters, and/or raw material components.
• Develop knowledge and support stabilization techniques (Liquid, lyophilization, etc.) for new products from development to Formulation and Freeze Drying (FFD) in Operations.
• Preparation, set up, operation and validation of equipment, raw materials, and consumables for studies. Maintain equipment and ensure it is kept in operational status.
• Operate in a compliant manner at all times with respect to documentation guidelines and current SOP’s related to experimentation, reporting data and training.
• Proactively ensures regulatory, GMP (when appropriate) and EHS compliance for region and local requirements.

Requirements

• Bachelors' degree from an accredited institution in a relevant scientific discipline such as Biological Sciences, Biochemistry, Formulation or Pharmaceutical Sciences.
• At least three (3) years of relevant experience preferred or, MS from an accredited institution in a relevant scientific discipline with industry experience preferred.
• Relevant lab skills with experience in sterile technique.
• Specific experience and knowledge in formulation development of biological products (vaccines, therapeutics).
• Experience in a matrix organization with the ability to interact and share knowledge in a global network of Formulation scientists.
• Statistical analysis of data experience is preferred.
• Bioprocess, analytical, or pharmaceutical formulation development is beneficial.
• Good organization skills and detail oriented.
• Prior experience with formulation of biological products and operation or understanding of stabilization methods.
• Participation on local and global multi-disciplinary teams.
• Ability to operate instrumentation/equipment and learn new technology and concepts.
• Concise and accurate reporting of technical data and information.
• Ability to troubleshoot problems and take corrective actions to solve the problem.
• Achievement focused with appropriate alignment for regulatory and quality requirements.
• Transparent communication, especially of risks, failures and learnings.
Positive attitude and willingness to work individually and in a team environment.

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.