Senior Engineer, Drug Product Process Development Job- Summit.

Title: Senior Engineer, Drug Product Process Development Job- Summit.
Source: MyJobHelper
Category: Healthcare, Other, Long-Term
Posted On: 2015-03-28T19:13:26.000-04:00
Description:
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

This position is responsible for process development, process characterization, scale-up, and technology transfer activities of small molecule drug products (DPs) for clinical development of new pharmaceutical products.

Responsibilities will include, but are not limited to, the following:

o Key member of a dynamic scientifically driven team, dedicated to the development and optimization of robust manufacturing processes for drug products.

o Serve as Drug Product Development representative on multidisciplinary CMC teams.

o Key contributor to process development strategies to define manufacturing processes for commercialization.

o Design and execute complex experiments to characterize drug product manufacturing processes utilizing various technologies.

o Apply fundamental engineering principles to characterize and solve process challenges across multiple unit operations, utilizing both experimental and process simulation/modeling approaches.

o Utilize appropriate research tools, instrumentation, technologies, and methodologies to support efficient and effective drug product process development.

o Manage and/or coordinate drug product process development/technology transfer to Contract Research/ Manufacturing Organizations.

o Prepare CMC regulatory documents.

o Serve as a resource of scientific and technical expertise.

o Assume departmental responsibilities for assigned projects and equipment.

o Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals.

o Prepare technical reports, publications and oral presentations.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

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Qualifications
Prerequisites:

Ph.D. with minimum 6 years experience in engineering or related field; or
M.S. with minimum of 8 years experience in engineering or related field; or.
B.S. with minimum of 10 years in engineering or related field.

Skills/Knowledge Required:

o Strong background in pharmaceutical development as it relates to formulation development and process development/optimization.

o Experience in leading scale-up and technology transfer, moving from laboratory to pilot plant and production scale.

o Experience across various solid oral dosage conventional and enabling manufacturing technologies.

o Demonstrated capability in execution of an experimental program to address issues of process robustness, productivity, and cost, integrating efforts with specialists in other technical disciplines. Demonstrated record of implementing novel and creative solutions to overcome process development obstacles.

o Working knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, engineering design, and statistical process control fundamentals.

o Working knowledge of cGMPs during pharmaceutical development and commercial manufacturing.

o Demonstrated proficiency in balancing resource requirements within projects and among multiple assigned projects.

o Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment. Ability to work independently or lead scientifically on cross functional assignments. Strong verbal and written communication skills are essential.

o Knowledge of applicable regulations, and experience with authoring relevant sections of regulatory filings (INDs/NDAs).

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Req ID: 15000331
Primary Location: United States-New Jersey-Summit
Job: Manufacturing
Organization: Celgene Corporation
Schedule: Regular
Shift: Standard
Employee Status: Individual Contributor
Job Type: Full-time
Job Level: Day Job
Travel: Yes, 20 % of the Time
Job Posting: 2015-02-24 00:00:00.0. Apply now!
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