Senior Scientist- Outsourcing Management
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb.
Around the world, we are passionate about making an impact on the lives of patients with serious disease.
Empowered to apply our individual talents and ideas so that we can learn and grow together.
And driven to make a difference, from innovative research to hands-on community support.
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment.
We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
The matrix leader will interface communications and provide analytical technical support between Analytical Sciences and Technology (AS&T) and Biologics External Manufacturing (BExM)/CROs for outsourced projects.
When required, this role will engage involvement from AS&T functional representatives.
Key Responsibilities include but are not limited to:
First line point-of-contact within AS&T for a broad range of technical support activities including non-routine testing investigations, method performance issues, method transfer/co-validation investigations/deviations, regulatory filing support, health authority inspections and method performance monitoring.
Technical Support for CMOs Technical Management of Non-BMS Testing Labs (CROs) Bridge effective and efficient communication between involved parties Monitor progress and provide concise updates to senior management for major investigations and issues that have potential market or regulatory impact Proactively identify and escalate risks On-site support for health authority inspections Assist with change controls, as required.
Assist with inspection preparations at CMOs/CROs Assist in any troubleshooting and investigations Ensure on-time delivery of commitments to/from CMOs/CROs Write/Review/Approve documentation as required (i.
e.
methods, protocols, reports) Contribute to CMC-filings as required Qualifications MS in Biochemistry, Chemistry, Biology or related field, with at least 8 or more years relevant work experience - preferably in the pharmaceutical or biotechnology industries.
OR PhD in Biochemistry, Chemistry, Biology or related field, with at least 5 or more years relevant work experience - preferably in the pharmaceutical or biotechnology industries Prior experience working with CMOs/CROs Demonstrated knowledge and understanding of analytical test methods for protein products.
Demonstrated knowledge of the biological drug development process and regulatory requirements for submissions and basic concepts of Good Manufacturing Practices (cGMP).
In-depth understanding of ICH guidelines for validations.
Ability to recognize potential gaps then articulate them to a broad base of Subject Matter Experts.
Previous Quality Control and inspection experience with regulatory authorities is beneficial.
Prior project management experience and ability to effectively manage projects in a matrix environment.
Proactive approach to problem solving Excellent oral and written communication skills Ability to work collaboratively in a team environment Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1502277.
Estimated Salary: $20 to $28 per hour based on qualifications.
One shared journey is moving us forward at Bristol-Myers Squibb.
Around the world, we are passionate about making an impact on the lives of patients with serious disease.
Empowered to apply our individual talents and ideas so that we can learn and grow together.
And driven to make a difference, from innovative research to hands-on community support.
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment.
We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
The matrix leader will interface communications and provide analytical technical support between Analytical Sciences and Technology (AS&T) and Biologics External Manufacturing (BExM)/CROs for outsourced projects.
When required, this role will engage involvement from AS&T functional representatives.
Key Responsibilities include but are not limited to:
First line point-of-contact within AS&T for a broad range of technical support activities including non-routine testing investigations, method performance issues, method transfer/co-validation investigations/deviations, regulatory filing support, health authority inspections and method performance monitoring.
Technical Support for CMOs Technical Management of Non-BMS Testing Labs (CROs) Bridge effective and efficient communication between involved parties Monitor progress and provide concise updates to senior management for major investigations and issues that have potential market or regulatory impact Proactively identify and escalate risks On-site support for health authority inspections Assist with change controls, as required.
Assist with inspection preparations at CMOs/CROs Assist in any troubleshooting and investigations Ensure on-time delivery of commitments to/from CMOs/CROs Write/Review/Approve documentation as required (i.
e.
methods, protocols, reports) Contribute to CMC-filings as required Qualifications MS in Biochemistry, Chemistry, Biology or related field, with at least 8 or more years relevant work experience - preferably in the pharmaceutical or biotechnology industries.
OR PhD in Biochemistry, Chemistry, Biology or related field, with at least 5 or more years relevant work experience - preferably in the pharmaceutical or biotechnology industries Prior experience working with CMOs/CROs Demonstrated knowledge and understanding of analytical test methods for protein products.
Demonstrated knowledge of the biological drug development process and regulatory requirements for submissions and basic concepts of Good Manufacturing Practices (cGMP).
In-depth understanding of ICH guidelines for validations.
Ability to recognize potential gaps then articulate them to a broad base of Subject Matter Experts.
Previous Quality Control and inspection experience with regulatory authorities is beneficial.
Prior project management experience and ability to effectively manage projects in a matrix environment.
Proactive approach to problem solving Excellent oral and written communication skills Ability to work collaboratively in a team environment Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1502277.
Estimated Salary: $20 to $28 per hour based on qualifications.
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