Lupin Pharmaceuticals (Company Headquarters)

Manager, Development Operations

1 week ago(1/12/2018 11:37 AM)
ID
2018-2238
# of Openings
1
Category
Specialty Product Development

Overview

Responsible for overseeing the progress of all pharmaceutics work with complex generic and brand products (which may include oral solids and liquids, thin films, topicals, and drug/device combination products) from early development to commercialization; will have responsibility for conducting product and process development activities in support of the company’s internal and collaborative drug development efforts. The candidate will be responsible for managing the pharmaceutics aspects and establish control strategies of our development programs. Currently all complex product development is conducted at third party contract facilities, and supporting these activities will require some travel. There is the potential that future development activities may (a) be brought back, in whole or in part, into a Lupin facility, and/or (b) be supported by the creation of an internal (to Lupin) pharmaceutical development laboratory.

Responsibilities

  • Manage and oversee the pharmaceutics component of new product development for a variety of different dosage forms, provide appropriate assistance as required to ensure that all product and process development work is conducted in line with current industry standards and regulatory guidelines.
  • Audit and evaluate contract development and manufacturing organization (CDMOs) GMP facilities to ensure that they are equipped with qualified equipment trains with the appropriate capacities, utilities, and EH&S/containment systems appropriate for contracted development activities. In addition, audit and evaluate techniques/procedures to ensure compliance with applicable regulations and appropriateness for contracted activities.
  • Review work activities conducted at CDMOs for completeness and compliance to the appropriate regulations. Some travel (~25%, potentially up to 50% depending on product portfolio mix) may be required to CDMOs as part of work activity review.
  • Develop appropriate product/process development project plans in collaboration with Director, Development Operations, and ensure relevant timelines are established and maintained. Provide updates to team members. Provide input into project budgets and monitor spending as appropriate.
  • Establish appropriate target product profiles (qTPPs), critical process parameters (CPPs), and critical quality attributes (CQAs) for Lupin’s product candidates and then review and assesses acquired composition and process development results to ensure that product profiles and critical attributes are met.
  • Knowledgeable with all aspects of small molecule pharmaceutical product development to include formulation and process development, equipment trains/unit operations pertinent to product portfolio, container closure systems and packaging equipment, process performance qualification (PPQ)/process validation, and drug/device combination products.
  • Knowledgeable of pharmaceutical drug product development using Quality-by-Design (QbD) concepts.
  • Knowledgeable with regulatory aspects for both New Drug Applications (NDAs) and abbreviated New Drug Applications (ANDAs). Assist in the preparation of relevant sections of CMC and other regulatory documentation as required.
  • Review and approve all pharmaceutics documents, including development/manufacturing protocols, batch records, development reports, and investigations. Create documents as required.
  • Maintain up-to-date records for all work performed and ensure a safe and productive workplace.
  • Manage and mentor scientific staff members, ensuring that all direct reports perform to an expected level and achieve established objectives.
  • Establish and maintain effective relationships with team members.
  • Comply with all Corporate guidelines and policies. Follow Corporate safety rules and procedures.
  • Co-ordinate pharmaceutics activities with those of the other Lupin R&D cross-functional project teams for maximum efficiency and to ensure company priorities are met.
  • Co-ordinate activities with other groups within Lupin to ensure projects progress in a timely manner, including procurement, support for corporate and FDA audits
  • Establish contacts with appropriate external resources and consultants as required to assist in the Corporate R&D efforts. This may include providing a critical assessment and recommendation of new processing techniques and equipment trains that may prove beneficial in the development of Lupin’s products.
  • Participate in the establishment of standard operating procedures, guidelines, expectations and documents for the R&D group and for contract groups.
  • Present analytical results and development activities to internal stakeholders, if requested.
  • As a technical resource for scientific staff members, offer guidance and advice to entire team.

Qualifications

 

 
  • Minimum 6 years’ experience in pharmaceutical technology or related fields with a PhD; Minimum 10 years’ experience in pharmaceutical technology or related fields with a MS; Minimum 15 years’ experience in pharmaceutical technology or related fields with a BS
  • Ability to interface with several diverse departments and cross-functional teams
  • High degree of proficiency and expertise in formulation development and principles of operation for process equipment used in manufacturing pharmaceutical dosage forms based primarily on small molecules.
  • Proven track record of scientific achievement as demonstrated by a successful record of R&D accomplishments and peer-reviewed publications.
  • Ability to work in a dynamic environment and to multitask.
  • Goal-oriented, attention to detail, proven ability to complete projects on time and within budget
  • Excellent team player.
  • Exceptional people management and leadership skills.
  • Strong communication (oral and written) communication and organizational skills.
  • A forward thinking, proactive person who can draw on past experience to make balanced and pragmatic decisions.
  • Superior computer proficiency, including standard office programs, presentation preparation, project planning tools and database searching.

 

Lupin-Somerset is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.

 

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed