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Aprecia Pharmaceuticals
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Senior Process Engineer
$99k-116k (estimate)
Full Time | Pharmaceutical 7 Months Ago
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Aprecia Pharmaceuticals is Hiring a Senior Process Engineer Near Blue Ash, OH

General Purpose of Position:Responsible for control and status of identified pharmaceutical processes and drug product manufacturing, which includes all aspects of support for process control, validation and testing to maintain cGMP compliant drug productPrimary Duties and Responsibilities (Essential Functions): 
Duties/Responsibilities
1 Review of late-stage Product Development efforts in formulation, process robustness and manufacturing controls, providing input for technology transfer or process validation required to achieve a successful transition
2 Provide support in the form of expertise and document ownership for each stage of development in the pharmaceutical development process as needed and product lifecycle activities within the Commercial Blue Ash Facility
3 Author manufacturing, packaging and in-process sections of Investigational New Drug (IND), New Drug Application (NDA) and Amended New Drug Application (ANDA) filings and supportive documents as directed
4 Review regulatory filings and generate needed documents for support
5 Perform risk analysis and assure appropriate parameters are evaluated with the needed statistical approach to associated testing for justification and support of critical process parameters and quality attributes
6 Collection and statistical evaluation of raw material critical quality attributes (CQA), in-process testing and critical process parameters (CPP) for continuous process improvement and annual report evaluations
7 Author and review technical memos, qualification/validation protocols and reports for cleaning and manufacture of drug product to demonstrate a state of control
8 Execute sampling and testing as needed for Technical Services protocols and Blue Ash, OH facility intermediate testing
9 Author and review SOPs (standard operating procedures) for production where the introduction of new products or processes are being addressed
10 Project management as delegated for technical transfer and continuous improvement efforts within Aprecia
11 Provide leadership and support for next generation equipment design. Includes Process Analytical Technology (PAT) design and implementation, powder dosaging, 3D printing, liquid delivery systems, and transport system technology

Reporting to this Position:No direct reportsTravel:Position may require 10-25% travel Work Shift: Responsibilities for this role may be covered across multiple shiftsKnowledge, Skills and Abilities:
  • Understanding of CMC (chemistry manufacturing and control) within validation and manufacturing of drug products
  • Experience in process control strategy and Quality Assurance systems with the pharmaceutical industry
  • Good organizational skills with a collaborative approach to problem solving
  • Statistical analysis and management of data
Education and Experience:
  • B.S. degree in Engineering, Chemistry, Math or a related discipline required
  • M.S. degree in Engineering, Chemistry, Math or a related discipline desired
  • 8-10 years of experience in the pharmaceutical industry integrated in late stage development or production support for oral dosage forms required
Physical Demands and Work Environment:
  • Good eyesight to read, interpret, and create technical materials
  • Good manual dexterity to operate computer and other general office equipment
  • Sitting at a desk or standing for extended periods of time
  • Occasional lifting of boxes (up to 25 pounds) containing engineering materials, manuals, tools, etc.
  • Exposure to odd body positions (i.e. twisted torso, bent over position, etc.) for brief periods of time while completing validation work in the laboratories or manufacturing areas taking samples, documenting batch information, etc.
  • Ability to wear appropriate PPE (personal protective equipment) as required for exposure to pharmaceutical operations (e.g. respirators, over-gowning, gloves, safety shoes, safety glasses, etc.) Uniforms, gloves, hairnet, and moustache cover and barrier outerwear is required within the manufacturing area
GENERAL INFORMATION:The expectation for all employees is to support the company’s mission, vision, culture and core values while adhering to all company policies. The above information is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. The position may require other duties as assigned and can be changed at any time by the company.We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Pharmaceutical

SALARY

$99k-116k (estimate)

POST DATE

08/24/2022

EXPIRATION DATE

06/20/2023

WEBSITE

aprecia.com

HEADQUARTERS

EAST WINDSOR, NJ

SIZE

100 - 200

FOUNDED

2004

TYPE

Private

CEO

PAT ZAFARINO

REVENUE

$5M - $10M

INDUSTRY

Pharmaceutical

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About Aprecia Pharmaceuticals

Aprecia Pharmaceuticals develops, manufactures and commercializes precision drug delivery systems and other related products.

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