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Job Requirements of Project Manager II:
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Employment Type:
Contractor
-
Location:
Cambridge, MA (Onsite)
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Project Manager II
Careers Integrated Resources Inc
Cambridge, MA (Onsite)
Contractor
Job Title: Project Manager II
Location: Cambridge, MA 02141
Contract Duration: 24 Months+ (Possibility of Extension)
Pay Range: $64 - $69/hr. on W2
Travel: Up to 20%
Employment Type: Full-Time
Position Overview:
Join the MSAT Synthetics and Oral Solids team to lead CMC pharmaceutical development for small molecule oral dosage forms (e.g., tablets, suspensions). You will manage technical operations through cross-functional collaboration with R&D, Regulatory, Supply Chain, and CMO/CRO partners, focusing on lifecycle management, manufacturing scale-up, and regulatory support.
Key Responsibilities:
Required Experience & Skills:
Basic Requirements:
Candidate Screening Checklist:
Location: Cambridge, MA 02141
Contract Duration: 24 Months+ (Possibility of Extension)
Pay Range: $64 - $69/hr. on W2
Travel: Up to 20%
Employment Type: Full-Time
Position Overview:
Join the MSAT Synthetics and Oral Solids team to lead CMC pharmaceutical development for small molecule oral dosage forms (e.g., tablets, suspensions). You will manage technical operations through cross-functional collaboration with R&D, Regulatory, Supply Chain, and CMO/CRO partners, focusing on lifecycle management, manufacturing scale-up, and regulatory support.
Key Responsibilities:
- Lead technical strategy execution for small molecule oral dosage forms
- Draft and implement product control strategies (QbD, risk assessments, etc.)
- Provide technical support to manufacturing for deviations and improvements
- Coordinate project plans, timelines, and cross-functional updates
- Support regulatory filing content, technical documentation, and dossier preparation
- Facilitate collaboration with internal sites and external CMOs/CROs
- Contribute to contract and quotation review (CDS, MSA, Quality Agreements)
Required Experience & Skills:
- 7+ years in pharmaceutical development, technical operations, or manufacturing (small molecules, oral dosage)
- Strong project management experience with multi-disciplinary teams
- Experience with regulatory filings, GMP compliance, and technical writing
- BS/MS in Chemistry, Pharmacy, or related field (MBA is a plus)
- Proficient in MS Office and project management tools
- Excellent verbal/written communication and presentation skills
- Experience working with international teams preferred
- Regulatory/Quality experience a plus
- French language skills a plus (not required)
Basic Requirements:
- Must be local or willing to relocate to Cambridge, MA
- Must comply with on-site presence requirements per company policy
- Must be open to up to 20% travel
Candidate Screening Checklist:
- 7+ years in pharma development/technical ops (small molecule oral forms)
- Proven project management of multi-functional technical teams
- Experience drafting regulatory documents and tech transfer protocols
- Located in or willing to relocate to Cambridge, MA
- Willing to travel up to 20%
- Strong written and verbal communication
- Comfortable with cross-functional collaboration and leading meetings
- Familiarity with QbD, GMP, CMO management
- (Preferred) Knowledge of French
- (Preferred) Background in Regulatory or Quality
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