Manufacturing Lead

Sterling-Hoffman Executive Search Located in: New Jersey
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JOB DESCRIPTION

Our client, a leading biopharmaceutical company, is currently seeking an accomplished Manufacturing Lead to join the team. Here is an overview of the role:

1) Provide technical guidance for troubleshooting and investigating complex issues
2) Apply statistical analysis for the interpretation of manufacturing data
3) Resolve complex technical issues and deviations
4) Communicate complex technical issues and deliver concise presentations to the Management
5) Provide technical inputs for selecting external contractors
6) Create and enhance collaborative and trustworthy relationships internally
7) Support analytical development and method validation for products' testing
8) Mentor employees in various aspects of analytical and problem-solving methodologies
9) Maintain a high-level of professional and technical expertise
10) Manage day-to-day contractors' activities for respective projects
11) Lead the interaction with contract manufacturers
12) Manage drug substances' manufacturing for registration, validation and commercial launch
13) Author and review quality documentation
14) Assist in responses to regulatory agencies regarding any pre- and post-approval changes
15) Author and review relevant drug substances and products' CMC sections
16) Maintain the awareness of current trends regarding global regulatory CMC requirements
17) Assist in development and implementation of departmental processes, procedures and 
policies
18) Maintain the adherence to departmental and quality systems
19) Supervise and coach less experienced staff, as needed
20) Contribute to preparation and coordination of internal audits and regulatory 
inspections

CRITICAL REQUIREMENTS

  • 1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field
    2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
    3) Recent experience in the biopharmaceutical industry is strongly preferred
    4) Preference will be given to candidates with recent experience in manufacturing

    This role is a great opportunity for the right person looking to advance their career with a wonderful company. If you are qualified and think that you are a strong fit for this role, please apply ASAP!

COMPANY INFORMATION

Sterling-Hoffman is a retained executive search firm that specializes in representing life sciences and technology companies in matters of high impact talent acquisition. Our clients include market leaders and venture capital-backed startups in industries such as: medical device, biotechnology, pharmaceuticals, enterprise software, clinical research, and laboratory services. You may view more of our jobs here: http://www.sterlinglifesciences.com Your privacy is important to us: we will never share your resume without your permission. Please note that only qualified applicants will receive a response. We encourage you to apply for as many jobs as you believe you are a fit for, but strongly suggest that you include your salary information as job seekers who provide salary information are likely to be reviewed sooner. ===================== TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Biotechnology Recruiter, Pharmaceutical Recruiter, Medical Device Recruiter, Biotechnology Career, Clinical Research Job, Regulatory Affairs Job, R&D / Scientist Job, Product Manager Job, Medical Device Sales Job, Biotechnology Sales Job, Quality Assurance Job, Engineering Job, Laboratory Jobs, Microbiology Jobs, CEO Jobs, Marketing Jobs, Manufacturing Jobs, Oncology Jobs, Cardiology Jobs, Hematology Jobs, Medical Jobs

JOB INFORMATION

Seniority Level:
Experienced - Not Management
Function:
  Manufacturing
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: