[jsfg_cinti] Job Posting: Formulation Scientist
- From: JSFG@xxxxxxxx
- To: JSFG@xxxxxxxx, jsfg_cinti@xxxxxxxxxxxxx
- Date: Tue, 14 Mar 2006 16:44:31 -0500 (EST)
The following job opportunity has been posted to the JSFG E-mail Mailing List.
Date: 03/14/06
JobTitle: Formulation Scientist
JobClass: Professional
JobDescript: -Serve as the senior technical advisor on all product initiatives.
1. Manage all aspects of product development proposals such as strategy and
objective of project, testing models, claims support, costs of project, timing,
regulatory implications and human resource requirements.
2. Manage contract formulators, scientists and testing labs. Establishes
standards, quality control and metrics criteria. Assists with testing plans and
monitors testing of formulations and products in vitro or in vivo.
3. Source testing resources, establishes testing protocols, supervises
clinical studies and reporting, and supervises quality control for all clinical
and lab testing.
4. Develop and recommend corporate-wide technical research policies and
programs necessary to support profitable growth and implement general policies
and goals of the organization.
5. Source, develop and work with CMO's to establish and administer procedures
pertaining to the development of new products, to alteration and improvement of
existing products, to extensions of their use and to control the quality of
products.
6. Manage pre-formulation and formulation studies of drug products such as
liquids, semi-solids, lyophilized and extended release products.
7. Oversee the writing of pre-formulation and formulation related stability
protocols and reports.
8. Oversee the writing of master batch records, compounding procedures and
establish finished product and in-process specifications.
9. Ensure that cGMP practices are followed and requirements met.
10. Analyze and/or review the results statistically.
11. Source raw materials, contract formulators and packaging vendors in
collaboration with operations. Assures specifications are in place to optimize
quality components from vendors in collaboration with regulatory and operations
departments.
12. Establish and maintain adequate records of client project information.
13. Advises operations of substandard vendor performance or products.
14. Actively participates in quality issues to assure we are managing
efficiently, reducing production delays and improving quality.
15. Direct product progress reports and ensure that all appropriate functional
executives receive progress notifications.
16. Establish and maintain relationships with industry influencers and ongoing
relationships with regional and national practitioners to support the
organization's product portfolio.
17. Represent company at trade association and scientific meetings.
Location: Cincinnati Area
Requirements_Qualif: Education and Experience:
-Ph.D. in Pharmacy, Chemistry/Biochemistry or related field with 5 - 7 years
pharmaceutical experience in research and development for product processing
and characterization of materials, process transfers, method qualification and
validation.
-Demonstrated knowledge of cGMP requirements.
-Demonstrated ability to manage multiple and diverse projects concurrently.
-Demonstrated ability to develop relationships and generate collaborations.
-Strong analytical skills; a strategic thinker, planner and implementer.
-Excellent written and verbal communication and presentation skills.
-Team player with high integrity and an open, interactive style with strong
interpersonal skills.
-Assertive, decisive and results-oriented
Language Skills:
- Ability to read, analyze, and interpret the most complex documents.
-Ability to respond effectively to the most sensitive inquiries or complaints
from customers, regulatory agencies or members of the business community.
-Ability to write speeches and articles.
-Ability to make effective and persuasive speeches and presentations on
controversial or complex topics to top management.
Mathematical Skills:
- Ability to apply advanced mathematical concepts such as exponents,
logarithms, quadratic equations and permutations. -Ability to apply
mathematical operations to such tasks as frequency distribution, determination
of test reliability and validity analysis of variance, correlation techniques,
sampling theory and factor analysis.
Reasoning Ability:
- Ability to apply principles of logical or scientific thinking to a wide range
of intellectual and practical problems.
-Ability to deal with nonverbal symbolism (formulas, scientific equations,
graphs, musical notes, etc.) in its most difficult phases.
-Ability to deal with a variety of abstract and concrete variables.
Technology Skills:
-To perform this job successfully, an individual should have knowledge of
internet software; project management, spreadsheet software and word processing
software.
Travel: Must be available to travel 25% of the time.
-Refer to Job Order # 4716
WorkType: Salaried
Travel: Yes
PositionState: New
SalaryRange: $$90-$120,000
HowApply_Email: Yes
Company: Remedy Intelligent Staffing
Person_Requesting_Profiles: Jamie Davidson
Contact_StreetAddress: Two Crowne Point Ct., Ste. 185
Contact_City: Cincinnati
Contact_State: oh
Contact_ZipCode: 45241
Contact_WorkPhone: 513-772-7008
Contact_FAX: 513-772-7147
email: cincy@xxxxxxxxxxxxxxx
Industry:
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