• Senior Scientist , Late Stage Drug Product Development Jobs in United States Of America - 25364634

  • Boehringer Ingelheim India Pvt Ltd
  • United States Of America, Usa
  • Save Job
  • 18 - 21 Years
  • Posted : above 1 month

Job Description:

Senior Scientist, Late Stage Drug Product Development - 1912958

Description

Global development of drug products, especially process development and optimization in scale-up and technical transfer to the manufacturing site, up to registration and international / global launch

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 Ingelheims high regard for our employees

Duties & Responsibilities

Development and optimization of robust and efficient Drug Product (DP) manufacturing processes in accordance with global regulatory requirements

Definition of global development strategies, trading off between development risk and resource and time constraints Lead of strategic initiatives improving the Drug product development process

Continuous refinement of the process development strategy by application of Quality by Design (QbD) elements and Process Analytical Technologies (PAT) in cooperation with the team risk management sciences, compliance and quality Pharmaceutical Sciences as well as advanced scale-up models to ensure state-of-the-art science and risk based development approaches Goal - Setting standards process development to improve BI Animal Health position as an industry wide leader in timely and cost effective process development

Evaluation and implementation of new technologies for Drug Product manufacturing and control, including harmonization within BI Animal Health manufacturing sites Goal - To ensure that BI animal Health has a technical leadership position in process development and allow for rapid development of innovative formulations

Monitoring of early development projects to give support and advice regarding early manufacturing process development to ensure manufacturability in commercial scale Goal - To anticipate future formulation outcomes and be ready to rapidly accept new product development opportunities as they become available

Responsible for authoring and review of major pharmaceutical submission documentation as well as provision of responses to authority questions

Ensuring that the teams are documenting development activities to support submission and patent applications

Responsible to independently conduct and lead projects (optimization, technical transfer, validation) with a volume of >= 1 year/ 2 Mio Euro

Proactively ensures regulatory, GxP and EHS compliance

Support clinical trial supplies in accordance with TPP and project plan; proactively lead projects to optimize clinical trial supply manufacturing and supplies

The output of this role is governed by regulatory GXP requirements globally Need to have alignment of activities with expectations of major regulatory agencies such as FDA-CVM and EMA This role also needs to ensure alignment with BI Quality standards and contemporary operating procedures of the Manufacturing group (Operations)

Requirements

PhD (or equivalent) in Pharmaceutical Technology or Engineering or Life Sciences and with at least 7 years of relevant experience in pharmaceutical product development and management

3 years of leadership experience (eg functional lead or project leader)

Leadership of interdisciplinary & cross-cultural teams

Strong interpersonal skills and communication skills

Operational and strategic thinking

Skilled in conflict resolution and negotiation

Achievement focused with appropriate alignment for regulatory and quality requirements

Willingness to travel internationally

Decision making skills are critical with the ability to solve problems with speed to change

Ability to act as or to support team heads and team members to become internal key-opinion leader

Transparent in communication of failures

Positive attitude and willingness to take risks

Ability to challenge teams and team heads and able to recommend innovative alternatives

Capability to deal with a variety of challenging matters including set-backs and failures

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

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 boehringer-ingelheimcom and join us in our effort to make more health

Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc, Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA Inc, Boehringer Ingelheim Animal Health Puerto Rico LLC and Boehringer Ingelheim Fremont, Inc is an equal opportunity and affirmative action employer committed to a culturally diverse workforce All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law

Job - Research & Development

Primary Location - Americas-US-NJ-North Brunswick

Organization - US-Boehringer Ingelheim Animal Health

Schedule - Full-time

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 09th Jun 2020

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