Job ID 4477 Company: Dechra Veterinary Products Job Location Portland, ME
Product Development Specialist (Portland, Maine)
Job RequirementsDechra is an international specialist veterinary pharmaceuticals products business. Our expertise is in the development, manufacture, and sales and marketing of high quality products exclusively for veterinarians worldwide.
3+ years experience in product development/analytical/manufacturing in a pharmaceutical setting
Must have strong interpersonal skills and be adaptable
Excellent computer skills (MS Office Suite, Adobe, Share Point) and an ability to pick up new systems & software quickly
Demonstrates strong analytical & organizational skills with the ability to handle multiple tasks and prioritize
Knowledge of administrative procedures and systems such as word processing, databases, managing files and records, designing forms, and other office procedures and terminology
Occasional travel may be required (domestic and international)
Job DescriptionThe Product Development Specialist is responsible to assist with CMC product development activities and create, edit, review and collate product development and regulatory documentation. Documentation includes manufacturing and analytical validation protocols/reports, Product Development Reports, stability protocols/reports and data summaries etc. Regulatory writing includes technical sections of Module 3 CTD sections with emphasis on manufacturing process and analytical method narratives.
The documentation process from various internal/ external development/ manufacturing partners is complex in nature and largely differs from partner to partner. It is therefore essential the candidate can adapt to various styles and levels of detail during document authoring and collation from various partners. Having the ability to standardize numerous technical data sets into a clear and concise narrative is essential.
The Product Development Specialist will work closely with subject matter experts, functional department personnel and key team members (both internal and external) to ensure timely development and accurate content of required documentation that Regulatory will submit to relevant regulatory authorities to support animal drug applications for a broad range of dosage types. The Product Development Specialist will be a member of the Product Development team and report to the Director, Product Development.
The ideal candidate must have a degree in life or physical sciences combined with broad experience in formulation development/ analytical methods/ manufacturing in a pharmaceutical setting. Previous experience with CMC technical writing and the ability to prepare CMC/regulatory documentation with significant independence is favored. A working knowledge of cGMPs and CTD format, excellent verbal and written communication skills, and collaboration skills with focus on timely delivery are critical. He/she should have 3+ years in the pharmaceutical industry. Significant experience in Microsoft office, Adobe are essential. Ability to analyze document sets and developing strategies and tactics for improvements is highly desirable. Results and detail-oriented, with the ability to prioritize and multi-task to produce high quality work is essential.
-Commercial and Business Acumen
- Project Management
- Relationship Management
- Results Focused
- Problem Solving
- Customer Service
- Product and Technical Knowledge
Behavior and Values:
(D) Committed to delivering excellence
(E) Enthusiastic and results driven
(C) Able to take calculated risks
(H) Honesty and integrity
(R) Team player
(A) Willing and able to go the extra mile
- Able to bring a creative approach to resolving issues
- Self-motivated, driven, and resourceful
- Highly organized and detail oriented
- Committed to ensuring projects are completed correctly and on time
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