|
Job Title
|
Regulatory Affairs Project
Manager
(APPLY NOW) |
|
Requisition No |
5907 |
|
Department
|
Regulatory
Affairs |
|
Job Type
|
Exempt,
Salaried, Regular Full-Time |
|
Shift
|
First
|
|
Job Summary
|
Responsible for managing the
regulatory aspects of projects/products, including the preparation
and submission of correspondences and applications to regulatory
agencies. Functions as a direct liaison with regulatory authorities
and facilitates the review and approval process of applications.
Leads and/or participates in project team meetings, by providing
regulatory support to ensure compliance with all FDA requirements.
Provides product approval strategies with limited oversight from the
Regulatory Affairs Program Manager. |
|
Qualifications
|
Qualified candidates will possess a
BS degree with 7-10 years, MS/PharmD 4-7 years, PhD 2-4 years,
pharmaceutical regulatory-related or equivalent experience required.
Excellent written, verbal, organizational and interpersonal skills
required. Scientific writing experience is required. Must be
detail-oriented and posses good problem solving skills. Must be
able to work independently, as well as within a team. Must be able
to manage and prioritize multiple projects to meet established
deadlines. |
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|
Job Title
|
Sr. IT Business Analyst
(APPLY NOW) |
|
Requisition No |
0803 |
|
Department
|
IT |
|
Job Type
|
Exempt,
Salaried, Regular Full-Time |
|
Shift
|
First
|
|
Job Summary
|
This position is responsible for supporting the SAP MM and PP
modules, including analysis, configuration, specification
development, support and project work. |
|
Qualifications
|
Qualified candidates will possess a Bachelor's degree plus 5 years
experience with SAP and at least 1 year of project management
experience in the MM and PP modules. A thorough understanding of
Supply Chain and Logistics with MRP and planning process
experience. Excellent communication and interpersonal skills.
Strong presentation and writing skills. Basic project methodology
understanding. Experience with a regulated industry preferred.
|
|
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|
Job Title
|
Controller
(APPLY NOW) |
|
Requisition No |
0815 |
|
Department
|
Finance |
|
Job Type
|
Exempt,
Salaried, Regular Full-Time |
|
Shift
|
First
|
|
Job Summary
|
Responsible for
all aspects of the company’s accounting and financial reporting
processes and systems, accounts payable and receivable, cash and
banking management, product costing, capital and expense management,
payroll processing, 401(k) plan compliance and financial
administration, state and federal government price reporting and
compliance, and all supporting internal control processes. The
position works with the company’s marketing and business development
departments to support the financial administration of key customer
and partner contracts, with operations to support product cost,
inventory and capacity management, with the financial planning and
analysis group to support business decision making, and with all
functional departments to support cost and budget management. The
position also works with outside tax, audit, legal, government, and
compliance partners to meet the broader financial and compliance
needs of the company stakeholders. The position oversees a staff of
10. |
|
Qualifications
|
Qualified candidates will have a CPA
and 8+ years of public accounting and /or relevant industry
experience, with demonstrated management and leadership skills.
Experience with automated ERP systems required (SAP strongly
preferred). |
|
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|
Job Title
|
Laboratory Analyst
(APPLY NOW) |
|
Requisition No |
0826 |
|
Department
|
Analytical
Development |
|
Job Type
|
Non-Exempt,
Salaried, Regular Full-Time |
|
Shift
|
First
|
|
Job Summary
|
Responsible for support of Product
Development Scientists and Chemists by performing and documenting
project oriented and routine testing in the Product Development
Laboratory and maintaining laboratory supplies and cleanliness.
|
|
Qualifications
|
Qualified candidates will have a four
year college degree, preferably in Chemistry. Training involving
the proper use of hazardous chemicals required. |
|
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|
Job Title
|
Stability Chemist I/Chemist II
(APPLY NOW) |
|
Requisition No |
0835 |
|
Department
|
Analytical
Development |
|
Job Type
|
Exempt,
Salaried, Regular Full-Time |
|
Shift
|
First
|
|
Job Summary
|
Responsibilities include: designing, initiating and maintaining
stability studies for development projects. Performs analytical
testing and coordinates contract testing on stability samples to
insure product quality, assist in setting appropriate specifications
for commercial products based on results and ongoing stability
studies. Preparation of relevant SOPs, protocols and stability
reports as requested. Assist project scientists with development
and validation of analytical procedures. |
|
Qualifications
|
Four-year college degree in Chemistry or related field, and 2-5
years of experience in an analytical GMP laboratory and HPLC
experience required. |
|
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|
Job Title
|
Marketing Department
Assistant
(APPLY NOW) |
|
Requisition No |
0830 |
|
Department
|
Sales & Marketing |
|
Job Type
|
Non-Exempt,
Salaried, Regular Full-Time |
|
Shift
|
First
|
|
Job Summary
|
Provide administrative assistance to support Marketing Manager (MM),
Product Managers (PMs), Tradeshow Specialist (TSS) and Senior
Director Sales & Marketing Operations (SDSMO). Also provides backup
support to Marketing Communications Specialist as needed. Position
requires dealing with some confidential information and the ability
to respect this. |
|
Qualifications
|
Qualifications include a high School diploma or equivalent, and one
to three years’ experience or college degree in Marketing, Business
or related field and no experience. Proficiency using a variety of
computer applications: Word, Excel, PowerPoint. SharePoint
experience preferred but not required. MAC ability in Quark-Xpress
and graphics programs such as Illustrator and PhotoShop preferred by
not required. Strong ability for: organization, attention to detail,
typing and proofing materials, establishing priorities, and meeting
deadlines. |
|
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|
Job Title
|
Microbiologist I or II
(APPLY NOW) |
|
Requisition No |
0822 |
|
Department
|
Microbiology Lab |
|
Job Type
|
Exempt,
Salaried, Regular Full-Time |
|
Shift
|
First
|
|
Job Summary
|
Provide technical
knowledge and serve as a resource for Quality Services, Product
Development, and other departments through projects and
assignments. |
|
Qualifications
|
Education and experience include a
four-year college degree in Microbiology and a minimum 3 years of
relevant experience; MS degree and a minimum of 1 year relevant
laboratory experience. Preferably experience in the pharmaceutical
industry or in a cGMP/FDA environment. |
|
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|
Job Title
|
QA Specialist I
(APPLY NOW) |
|
Requisition No |
0836 |
|
Department
|
Quality Systems
|
|
Job Type
|
Exempt,
Salaried, Regular Full-Time |
|
Shift
|
First
|
|
Job Summary
|
The purpose of the
Quality System Specialist is to support Quality Assurance in the
Quality Systems areas including annual product reviews, complaints,
investigations, document control, and GMP training, and to support
production and in-house label formatting. |
|
Qualifications
|
Education and experience include a college degree in
related subject matter (chemistry, biology, or similar) and a
minimum of 1
years experience in a regulated
industry. Previous experience in the pharmaceutical industry is
preferred. Strong technical writing skills, experience in report
generation, analytical thinking, and
computer skills for word
processing, charting, and trending, as well as creating/maintaining
relational databases, i.e. Access, SAP.
are crucial. An
understanding of a service-oriented position is necessary. |
|
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