Process Expert

4 weeks ago

Millburn, United States Novartis Full time

**Summary**:
**About the Role**:
**Key Responsibilities**:

- Manage and maintain manufacturing documentation including Master Batch Record, applicable SOPs, risk assessments, protocols, and other documentation as needed.
- Technical writing/Reviewing to support manufacturing operations including but not limited to, Standard Operating Procedures (SOP), batch records and white papers.
- Collect data for ongoing process verification (OPV), support tracking and evaluation of product performance and implementation of CAPAs.
- Authoring/Owning investigations related to material transfer, API synthesis, Drug Substance formulation, Drug product filling, inspection, and packaging.
- Ensure processes are inspection ready at all times.
- Support process optimization and new technology introduction for continued productivity improvement, as appropriate.
- Review validation protocols and reports. Support the execution of process validations, and short-term improvement projects.
- Provide guidance and support to production team through training and knowledge sharing.

**Shift**:This shift schedule for this role is **Wed-Sat**, 10am-8:30pm **OR** 1pm-11:30pm, located on-site at our Millburn, NJ location.

**Essential Requirements**:

- Bachelor's degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry or relevant experience in lieu of degree.
- 3 years’ experience in a process support shop floor role in GMP manufacturing and/or QA/QC.
- Proven process understanding (Pharma, GMP, Regulatory aspects).
- Demonstrated in-depth experience with manufacturing related investigations required. Strong affinity with and awareness of quality issues.
- Excellent technical writing skills

**Desirable Requirements**:Previous Radio pharma experience a plus

The pay range for this position at commencement of employment is expected to be between $84,000 to $126,000 per year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Division

Operations

Business Unit

Pharmaceuticals

Location

USA

Site

Millburn

Company / Legal Entity

U469 (FCRS = US469) AAA USA Inc.

Functional Area

Technical Operations

Job Type

Full time

Employment Type

Regular

Shift Work

No

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