Manager, Pharmaceutical Development

5 - 7 years experience  •  Manufacturing / Diversified

Salary depends on experience
Posted on 11/28/17
Greenville, NC
5 - 7 years experience
Manufacturing / Diversified
Salary depends on experience
Posted on 11/28/17

Summary

To lead the group responsible for the development of pharmaceutical dosage forms,

and to execute pharmaceutical portions of technology transfers. To assure that

products, processes, and/or procedures are rapidly developed and meet customer

expectations and all applicable regulatory requirements.

Key Requirements

1. Ensure the rapid development of new dosage forms and processes according to

customer requirements. Assure that processes are safe, reproducible, cost

effective, environmentally sound and can be successfully validated and

transferred to production operations, in order to meet agreed standards and

require minimal continuing support. Look for ways to improve customer

satisfaction.

2. Assist Marketing in obtaining clients and business partners. Review technical

packages, develop project proposals and provide information to be included in

contractual agreements.

3. Manage the production of clinical supplies such that customer and regulatory

requirements are met. 2

4. Ensure that the Chemistry, Manufacturing, and Controls portion of regulatory

submissions are based on sound science and written to current standards with

the reviewer in mind. To be accountable for the preparation of appropriate CMC

Documentation.

5. Work with Client Departments to introduce new technology and resolve problems,

as needed.

6. Define resource needs (capital, expense, and headcount) so that current and

future development needs are met. Recruit, hire, retain, train, and motivate a

scientifically competent staff. Provide opportunities for staff career development.

7. Performs other duties as assigned.

Qualifications

BS/BA with 7 years relevant experience OR

MS with 5 years relevant experience OR

Ph.D. with 3 years relevant experience

9 years experience with a degree in a related scientific field.

-Demonstrated ability to manage and lead professional staff in order to achieve goals,

evaluate and resolve complex technical problems. Ability to motivate, energize, and

retain key staff by direct interactions with supervisors and staff. Must have a broad

based knowledge of product development/product manufacturing or analytical

development/testing techniques, as appropriate, and CMC regulatory requirements.

Not the right job?
Join Ladders to find it.
With a free Ladders account, you can find the best jobs for you and be found by over 20,0000 recruiters.