BDO USA, LLP
Manager, BPTG
BDO USA, LLP, Chicago, IL
Job Description
Job Summary:
Under the supervision of a Managing Director, the Manager, BioProcess Technology Group (BPTG) will provide support for consulting projects in biopharmaceutical development, including but not limited to analytical method development, method validation, method transfer, quality control release and stability analysis, and regulatory compliance. This role is expected to actively participate in client interactions as needed. In addition, the Manager will support internal firm projects and initiatives, including thought leadership and firm building.
Job Duties:
Supervisory Responsibilities:
Qualifications, Knowledge, Skills, and Abilities:
Education:
Experience:
License/Certifications:
Software:
Language:
Other Knowledge, Skills, & Abilities:
Individual salaries that are offered to a candidate are determined after consideration of numerous factors including but not limited to the candidate's qualifications, experience, skills, and geography.
National Range: $105,000 - $130,000
NYC/Long Island/Westchester Range: $105,000 - $130,000
About Us
Join us at BDO, where you will find more than a career, you'll find a place where your work is impactful, and you are valued for your individuality. We offer flexibility and opportunities for advancement. Our culture is centered around making meaningful connections, approaching interactions with curiosity, and being true to yourself, all while making a positive difference in the world.
At BDO, our purpose of helping people thrive every day is at the heart of everything we do. Together, we are focused on delivering exceptional and sustainable outcomes and value for our people, our clients, and our communities. BDO is proud to be an ESOP company, reflecting a culture that puts people first, by sharing financially in our growth in value with our U.S. team. BDO professionals provide assurance, tax and advisory services for a diverse range of clients across the U.S. and in over 160 countries through our global organization.
BDO is the first large accounting and advisory organization to implement an Employee Stock Ownership Plan (ESOP). A qualified retirement plan, the ESOP offers participants a stake in the firm's success through beneficial ownership and a unique opportunity to enhance their financial well-being. The ESOP stands as a compelling addition to our comprehensive compensation and Total Rewards benefits* offerings. The annual allocation to the ESOP is fully funded by BDO through investments in company stock and grants employees the chance to grow their wealth over time as their shares vest and grow in value with the firm's success, with no employee contributions.
We are committed to delivering exceptional experiences to middle market leaders by sharing insight-driven perspectives, helping companies take business as usual to better than usual. With industry knowledge and experience, a breadth and depth of resources, and unwavering commitment to quality, we pride ourselves on:
*Benefits may be subject to eligibility requirements.
Equal Opportunity Employer, including disability/vets
Click here to find out more!
Job Summary:
Under the supervision of a Managing Director, the Manager, BioProcess Technology Group (BPTG) will provide support for consulting projects in biopharmaceutical development, including but not limited to analytical method development, method validation, method transfer, quality control release and stability analysis, and regulatory compliance. This role is expected to actively participate in client interactions as needed. In addition, the Manager will support internal firm projects and initiatives, including thought leadership and firm building.
Job Duties:
- Provides consulting services, independently or under the direction of the Managing Director, in the areas of biopharmaceutical analytical method development, phase appropriate qualification, validation, characterization and quality control release and stability analysis
- Provides support in reviewing client-specific analytical data and compiling and analyzing results for inclusion into regulatory and quality documents
- Provides support in drafting and reviewing client-specific analytical reports, regulatory and quality documentation and in auditing CMOs and CROs under the supervision of the Lead Auditor
- Provides support in managing client internal research programs and outside service providers, including tracking and distributing materials, reagents, and/or information as needed between vendors and client sites
- Performs necessary project related tasks within time and budget, consults with project lead to discuss the appropriate action if allotted budget or time is to be exceeded
- Identifies interactions with clients or on behalf of clients requiring the involvement of Managing Directors and actively solicits this additional resource
- Provides necessary support for internal Firm operations and initiatives (i.e., BPTG Projects):
- Supports BPTG's business development efforts
- Supports other internal initiatives, such as protocol and report template authoring
Supervisory Responsibilities:
- Supervises client engagements, maintains client relations, and provides client support
- Oversees assigned Senior Associates and Associates
- Acts as a career advisor to Senior Associates and Associates
Qualifications, Knowledge, Skills, and Abilities:
Education:
- Bachelors degree in Natural Sciences, Bio Engineering, or Life sciences, required
Experience:
- Five (5) or more years of experience in the biopharmaceutical industry, required
- Experience in a CMC related technical role supporting analytical method development and qualification of test methods for biopharmaceutical or biologic products, preferred
- In-depth knowledge of or experience developing / qualifying analytical methods such as SE-UPLC, rCE-SDS, nrCE-SDS, icIEF, binding assays and process residual assays (ELISA, qPCR), preferred
- Experience as a contributor to regulatory submissions, preferred
License/Certifications:
- N/A
Software:
- Proficient in the use of Microsoft Office Suite, specifically Excel, Word, and PowerPoint, required
- Experience with JMP or similar statistical tools, preferred
- Working knowledge of AI tools for data compilation and document writing, preferred
Language:
- N/A
Other Knowledge, Skills, & Abilities:
- Excellent verbal and written communication skills, specifically authoring analytical documents such as development reports, qualification protocols/reports and characterization reports
- Strong quantitative analytical and basic research skills
- Solid organizational skills especially ability to meet project deadlines with a focus on details
- Ability to successfully multi-task while working independently or within a group environment
- Ability to work in a deadline-driven environment and handle multiple projects simultaneously
- Ability to follow and apply specific rules and regulations
- Self-motivated and ability to work with minimal supervision
- Ability to collaborate well with others and maintain a flexible mindset
Individual salaries that are offered to a candidate are determined after consideration of numerous factors including but not limited to the candidate's qualifications, experience, skills, and geography.
National Range: $105,000 - $130,000
NYC/Long Island/Westchester Range: $105,000 - $130,000
About Us
Join us at BDO, where you will find more than a career, you'll find a place where your work is impactful, and you are valued for your individuality. We offer flexibility and opportunities for advancement. Our culture is centered around making meaningful connections, approaching interactions with curiosity, and being true to yourself, all while making a positive difference in the world.
At BDO, our purpose of helping people thrive every day is at the heart of everything we do. Together, we are focused on delivering exceptional and sustainable outcomes and value for our people, our clients, and our communities. BDO is proud to be an ESOP company, reflecting a culture that puts people first, by sharing financially in our growth in value with our U.S. team. BDO professionals provide assurance, tax and advisory services for a diverse range of clients across the U.S. and in over 160 countries through our global organization.
BDO is the first large accounting and advisory organization to implement an Employee Stock Ownership Plan (ESOP). A qualified retirement plan, the ESOP offers participants a stake in the firm's success through beneficial ownership and a unique opportunity to enhance their financial well-being. The ESOP stands as a compelling addition to our comprehensive compensation and Total Rewards benefits* offerings. The annual allocation to the ESOP is fully funded by BDO through investments in company stock and grants employees the chance to grow their wealth over time as their shares vest and grow in value with the firm's success, with no employee contributions.
We are committed to delivering exceptional experiences to middle market leaders by sharing insight-driven perspectives, helping companies take business as usual to better than usual. With industry knowledge and experience, a breadth and depth of resources, and unwavering commitment to quality, we pride ourselves on:
- Welcoming diverse perspectives and understanding the experience of our professionals and clients
- Empowering team members to explore their full potential
- Our talented team who brings varying skills, knowledge and experience to proactively help our clients navigate an expanding array of complex challenges and opportunities
- Celebrating ingenuity and innovation to transform our business and help our clients transform theirs
- Focus on resilience and sustainability to positively impact our people, clients, and communities
- BDO Total Rewards that encompass so much more than traditional "benefits." Click here to find out more!
*Benefits may be subject to eligibility requirements.
Equal Opportunity Employer, including disability/vets
Click here to find out more!