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Associate Director, Pharmaceutical Technology Job. Job in Berkeley Heights, New Jersey, United States in Celgene Corporation. Nelest.com
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Associate Director, Pharmaceutical Technology Job

col-narrow-left   

Job ID:

23216

Location:

Berkeley Heights, NJ 

Job function:

Manufacturing / Operations
col-narrow-right   

Posted:

03.11.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Associate Director, Pharmaceutical Technology Job

Job 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.

The primary role of this position is to lead, manage, and coordinate internal and outsourced drug product manufacturing processes for Celgene pipeline products. This position will play a central role in the planning and execution of projects to advance the development of the Company's product candidates. Products may be at later phases of development or at commercial scale. The position is also responsible to transfer products to manufacturing sites as required.

Roles & Responsibilities:

The primary role of this position is to provide operational leadership for process scale up and improvement programs. A thorough understanding of drug product and process technologies is required. Multiple programs will be operational at the same time therefore time management and the ability to multitask are considered critical job responsibilities. Approximately 70% of the actual work will be performed by contract manufacturing organizations under the direction of this position. Therefore, strong communication skills and the ability to appropriately represent Celgene are required. Specific responsibilities of this position will include:

- Provide feedback on formulation and process feasibility
- Define, develop and implement pharmaceutical process strategies based on scientific, technical, regulatory, and market place needs
- Develop project plans which define timing, resources and overall project costs
- Evaluate, recommend and oversee contract manufacturing organizations (CMO) capable of providing the technical services required. Provide financial and administrative oversight on CMO's
- Act as the primary representative to internal and external clients for dosage form process scale-up
- Lead, guide, and direct in executing process optimization, and validation studies
- Lead the resolution of technical issues related to products in development or in commercial.
- Coordinate project activities with other internal functions such as Regulatory Affairs, Quality Assurance, Analytical R&D, Sales/Marketing, etc.
- Author, review and approve CMC related documentation as required for the market application
- Interact with FDA/EMA regulatory authorities as required
- Responsible for Change Control and CAPA's
- Partner in continuous improvement projects. Contribute to department goals
*LI-KM1

Job Requirements:


Qualifications:
- Broad based knowledge of pharmaceutical manufacturing
- Background in drug process development with demonstrated expertise in solid dosage forms, and drug delivery technologies. Should be familiar with semi-solid, and liquid dosage forms
- Understand impact of drug substance on drug product performance
- Ability to evaluate, and share data across functions for evidence based decision making
- Proven ability in pharmaceutical process scale-up and improvements
- Lead, and participate in technology transfer activities
- Lead Scale-up and Process Validation activities
- Strong communications skills with a team oriented approach
- Project Management skills including the ability to prioritize, schedule and manage multiple projects and resources simultaneously
- Working knowledge of international GMP requirements and quality systems
- Working knowledge of current regulatory guidelines (EMA and FDA)

Requirements & Education:

A Ph.D. in pharmaceutical science, chemical engineering, or related discipline with a minimum of 11 - 13 years of relevant industry experience or a MS or BS degree with 16 years in pharmaceutical processes. This individual must be highly motivated and enjoy working in a fast paced, challenging matrix environment. The individual should be able to interact cross-functionally at all levels internally within Celgene, and externally with consultants/contractors and business partners. The candidate must be flexible relative to responsibilities. Approximately 30% to 40% travel, both domestic and international, is required.

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.

Travel: Yes, 25 % of the Time

Zip Code:

07922

Company Info
Celgene Corporation
86 Morris Avenue
Summit, NJ, United States

Phone: +1-908-673-9000, +41 32 729 85 00, 1-908-673-9800, 1-908-673-9800
Web Site: www.celgene.com

Company Profile

Company Info


Celgene Corporation
86 Morris Avenue
Summit, NJ, United States
Phone: +1-908-673-9000, +41 32 729 85 00, 1-908-673-9800, 1-908-673-9800
Web Site: www.celgene.com

Associate Director, Pharmaceutical Technology Job

col-narrow-left   

Job ID:

23216

Location:

Berkeley Heights, NJ 

Job function:

Manufacturing / Operations
col-narrow-right   

Posted:

03.11.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Associate Director, Pharmaceutical Technology Job

Job 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.

The primary role of this position is to lead, manage, and coordinate internal and outsourced drug product manufacturing processes for Celgene pipeline products. This position will play a central role in the planning and execution of projects to advance the development of the Company's product candidates. Products may be at later phases of development or at commercial scale. The position is also responsible to transfer products to manufacturing sites as required.

Roles & Responsibilities:

The primary role of this position is to provide operational leadership for process scale up and improvement programs. A thorough understanding of drug product and process technologies is required. Multiple programs will be operational at the same time therefore time management and the ability to multitask are considered critical job responsibilities. Approximately 70% of the actual work will be performed by contract manufacturing organizations under the direction of this position. Therefore, strong communication skills and the ability to appropriately represent Celgene are required. Specific responsibilities of this position will include:

- Provide feedback on formulation and process feasibility
- Define, develop and implement pharmaceutical process strategies based on scientific, technical, regulatory, and market place needs
- Develop project plans which define timing, resources and overall project costs
- Evaluate, recommend and oversee contract manufacturing organizations (CMO) capable of providing the technical services required. Provide financial and administrative oversight on CMO's
- Act as the primary representative to internal and external clients for dosage form process scale-up
- Lead, guide, and direct in executing process optimization, and validation studies
- Lead the resolution of technical issues related to products in development or in commercial.
- Coordinate project activities with other internal functions such as Regulatory Affairs, Quality Assurance, Analytical R&D, Sales/Marketing, etc.
- Author, review and approve CMC related documentation as required for the market application
- Interact with FDA/EMA regulatory authorities as required
- Responsible for Change Control and CAPA's
- Partner in continuous improvement projects. Contribute to department goals
*LI-KM1

Job Requirements:


Qualifications:
- Broad based knowledge of pharmaceutical manufacturing
- Background in drug process development with demonstrated expertise in solid dosage forms, and drug delivery technologies. Should be familiar with semi-solid, and liquid dosage forms
- Understand impact of drug substance on drug product performance
- Ability to evaluate, and share data across functions for evidence based decision making
- Proven ability in pharmaceutical process scale-up and improvements
- Lead, and participate in technology transfer activities
- Lead Scale-up and Process Validation activities
- Strong communications skills with a team oriented approach
- Project Management skills including the ability to prioritize, schedule and manage multiple projects and resources simultaneously
- Working knowledge of international GMP requirements and quality systems
- Working knowledge of current regulatory guidelines (EMA and FDA)

Requirements & Education:

A Ph.D. in pharmaceutical science, chemical engineering, or related discipline with a minimum of 11 - 13 years of relevant industry experience or a MS or BS degree with 16 years in pharmaceutical processes. This individual must be highly motivated and enjoy working in a fast paced, challenging matrix environment. The individual should be able to interact cross-functionally at all levels internally within Celgene, and externally with consultants/contractors and business partners. The candidate must be flexible relative to responsibilities. Approximately 30% to 40% travel, both domestic and international, is required.

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.

Travel: Yes, 25 % of the Time

Zip Code:

07922
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