Job Description

Job Summary:

A Managing Director provides strategic, technical, and/or regulatory CMC consulting services to biopharmaceuticals clients of BDO either independently or in collaboration with other Managing Directors, Directors, Managers, etc. The Managing Director is an expert resource in bioprocess related technical matters for other employees in support of client needs, help enhance the internal knowledge base and operational efficiencies and serve as a manager and/or mentor to more junior staff.

Job Duties

Provides team based and independent consulting services in the areas of process development, validation, manufacturing, facilities design, for recombinant proteins, drug conjugates, cell and gene therapies, vaccines and other biological products
Works with business lead to identify the required scope of work (SOW) and prepare a description, suitable and sufficient for inclusion in proposals or contract submissions to the client
Manages projects according to the SOW and the budget and clearly communicates team member roles and responsibilities as well as the applicable budgeted time
Develops and leads a team of staff and subcontractors to efficiently and successfully complete the contracted SOW within time and budget
Identifies when the client requests exceed the contracted SOW and discuss with the client and the business lead the necessary expansion of SOW and potentially the budget
Identifies when client needs change and adjust the project plan as reasonable is it does not exceed the budgeted time and expense associated with the project
Acts as Project Leader to manage overall client programs as the client’s single point of technical contact and access subject matter experts for input in specific program requirements
Develops phase-appropriate analytical process characterization and validation approaches, including detailed analysis of CMC-related data and the authoring or reviewing of reports and regulatory submissions
Conducts market research, technology assessment, and due diligence reviews and lead discussions or presentations with clients during project calls or meetings to present findings and provide suitable advice and assistance in client decision-making

The Managing Director Shall Also Provide Necessary Support For Internal Company Operations And Initiatives. This Work May Include, But Is Not Limited To

Leads or participates in business development for the Company by developing relationships with current and prospective clients, working on expanding current projects to include additional scope, initiate or actively engage in sales calls and in drafting proposals and contracts, attending and speaking at conferences, and contributing to marketing materials
Prepares blogs, white papers, and peer-reviewed papers for publication in relevant journals, highlighting BDOs expertise, knowledge, experience, and familiarity with current process performance expectations and should be generally consistent with other publications
Seeks out and participates in speaking opportunities globally to better publicize the BDO brand
Participates in internal management including, as requested, resource allocation for new projects for which the Managing Director is the Project Leader, recruiting and interviewing candidates for positions, scheduling and hosting lunch and learn seminars, and performing internal knowledge management activities
Participates in BDO’s social media outreach, marketing, and other functions as requested

Education

Qualifications, Knowledge, Skills, and Abilities:

An advanced degree in Chemical Engineering, Pharmaceutical Sciences, or other field relevant to the life sciences industry, required
Ph.D., preferred

Experience

Subject matter expert (SME) in one or more of these CMC areas: cell line development, fermentation and/or mammalian cell culture, and down stream purification of recombinant proteins and monoclonal antibodies, required
Fifteen (15) or more years of real experience in a CMC-related field within the pharmaceutical or biopharmaceutical industry, required
Experience leading a group and/or working in a matrixed organization, required
Knowledgeable in identification of a problem’s solutions, required
Author of one or more regulatory submission sections for multiples products, required
Experience in drug conjugate chemistry, including bioconjugates, ADCs or radio-therapeutics, preferred
Five (5) or more years of experience in a consulting role, preferred

Software

Proficient in the use of Microsoft Office Suite, specifically Excel, Word, and PowerPoint; and Teams and Sharepoint, required

Other Knowledge, Skills & Abilities

Excellent verbal and written communication skills, specifically business / report writing
Attention to detail
Strong problem solving skills
Solid organizational skills with ability to meet project deadlines and a focus on detail
Ability to successfully multi-task while working independently or within a group setting
Proven ability to work in a deadline-driven environment and handle multiple projects simultaneously
Ability to follow and apply specific rules and regulations
Ability to work with minimal supervision
US citizenship required

About Us

BDO delivers assurance, tax, digital technology solutions and financial advisory services to clients throughout the country and around the globe. We offer numerous industry-specific practices, world-class resources, and an unparalleled commitment to meeting our clients’ needs. We currently serve more than 400 publicly traded domestic and international clients.

Unparalleled partner-involvement
Deep industry knowledge and participation
Geographic coverage across the U.S.
Cohesive global network
Focused capabilities across disciplines

BDO brings world-class resources and exceptional service to each and every one of our clients. BDO USA is a member of BDO International, the world’s fifth largest accounting network.

BDO offers a competitive Total Rewards package that encompass so much more than – “traditional benefits”. Our wide range of rewards and our employees’ ability to customize rewards to their individual needs are two of the reasons why BDO has been honored with so many workplace awards, including 100 Best Companies for Working Parents, Working Mother 100 Best Companies, Top Entry Level Employer, 2022 National Best & Brightest Companies to Work For and more.

Some Examples Of Our Total Rewards Offerings Include

Competitive pay and eligibility for an annual performance bonus.
A 401k plan plus an employer match
Comprehensive, medical, dental, vision, FSA, and prescription insurance from day one
Competitive Paid Time Off with daily accrual from day one of employment, plus paid holidays
Paid Parental Leave
Adoption Assistance
Firm paid life insurance
Wellness programs
Additional offerings include BDO Flex, Group Legal insurance, Pet insurance and Long-Term Care Insurance

Above offerings may be subject to eligibility requirements.

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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

"BDO USA, P.A. is an EO employer M/F/Veteran/Disability"

BDO USA

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Managing Director, Life Sciences