Dir/Sr. Dir, Analytical R&D

About Orchestra BioMed

Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s lead product candidate is atrioventricular interval modulation (AVIM) therapy (also known as BackBeat Cardiac Neuromodulation Therapy (CNT™)) for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed is also developing the Virtue ® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. For further information about Orchestra BioMed, please visit biomed.com and follow us on Linkedin.com

Job Summary

The Director/Sr. Director Analytical R&D will support the development and registration for pre-clinical and late stage pharmaceutical candidates. This person will manage and oversee analytical activities performed in-hours and at CROs/CDMOs associated with method development, qualification/validation, transfer and characterization for drug substance and drug product. The is an in-person position located in our New Hope, PA office reporting to the VP R&D.

Responsibilities – Including but not limited to:

• Manage and oversee analytical activities performed in-house and at CROs/CDMOs associated with method development, qualification/validation, transfer and characterization for drug substance and drug product
• Lead on-going or new projects and take ownership of analytical requirements needed, including scheduling, prioritizing and coordinating analytical testing
• Apply advanced scientific principles, theories and concepts to a broad range of research problems and develop innovative solutions for analytical problems related to drug products in compliance with appropriate Standard Operating Procedures (SOPs) and regulatory guidelines
• Direct/perform analytical method development activities in-house and at CROs/CDMOs including identification of impurities and degradation products, reference standard qualification and physical characterization
• Develop method validation and transfer strategies to CROs/CDMOs
• Design experimental plans as per current FDA/ICH guidance, critically analyzes data and information gathered.
• Define and execute effective analytical strategies to characterize micro/nano particle formulations
• Support testing required for drug product process development, characterization of impurities and other activities associated with GLP and cGMP Clinical Trial materials
• Author/review key documents as required such as: analytical test methods, study protocols, reports, relevant sections of regulatory filings and deficiency responses
• Prepare technical reports, presentations as required
• Monitor and report progress of AD project deliverables within agreed project timelines
• Collaborate with other groups and activities necessary to ensure project deliverables are met
• Assure all laboratory documentation and other regulatory compliance systems are maintained according to corporate standards
• Partner with Quality Assurance and Regulatory Affairs-CMC to ensure completion of appropriate documentation and maintenance of high-quality standards
• Maintain QMS training in compliance with internal SOP
• Lead analytical R&D team
• Other duties as assigned
• Approximately 5% travel is anticipated

Qualifications – Knowledge & Skills:

• Ph.D. in Chemistry (or related field) with 10+ years of relevant R&D experience, M.S. or B.S in Chemistry (or related field) with 14+ years of relevant R&D experience
• Relevant pharmaceutical industry experience in early to late-stage product, CQA assessment; strong understanding of product development disciplines and relationship of analytical requirement to drug development
• Working experience with analytical method development, verification, validation and method transfer
• Experience in analyzing and characterization of polymers preferred
• Experience collaborating with third parties (CROs/CDMOs) and in developing the strategies for method validation and transfer activities
• Experience with analytical methodologies to characterize nano/micro particle formulations (such as PSD, Zeta potential) with hands on experience in method development and validation of in-vitro release testing
• Experience in bioanalytical method development and validation is preferred
• Theoretical and hands-on knowledge and experience with analytical methodologies for drug substance and drug product characterization
• Proficient with common analytical techniques and instrumentations: separation techniques (e.g., HPLC, GC, TLC), in-vitro dissolution, general/wet chemical methods, physical characterizations (e.g., particle size analysis via DLS, TEM/SEM, zeta potential), spectroscopy (e.g., UV/Vis, FTIR) and thermal methods (e.g., DSC, TGA).
• Experience in authoring analytical related regulatory docs to support filing
• Ability to work in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities
• Experience in authoring and drafting the responses to FDA deficiencies, justifications and relevant regulatory sections

A c urrent US work authorization is required in order to be employed by Orchestra BioMed . The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. The level of this position will be based on the final candidate’s qualifications.

Why Join Orchestra BioMed

In addition to an interesting, inclusive, and collaborative work environment, Orchestra BioMed is proud to offer a comprehensive compensation package. Along with a competitive salary, including annual bonus and equity eligibility, health insurance (for employee and family), prescription drug coverage, 401(k), paid holidays, PTO & sick time, Life & AD&D insurance, disability insurance, dental, vision, pet insurance and more.

Our Vision

To be a leader in bringing high impact medical innovations to life through risk-reward sharing partnerships.

  Our Mission

We will work passionately to apply our collaboration-based business model to bring high-impact medical innovations to live and create extraordinary value for patients, care providers, partners and stakeholders.

  Our Values

We care  about patients, physicians, partners, and each other

We are creative , open-minded, adaptable and think “outside the box”

We are driven  to always do our best and we do not give up

We deliver  and are accountable to promised results

EQUAL OPPORTUNITY EMPLOYER Orchestra BioMed is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information, and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.

Important notice to employment businesses/agencies

Orchestra BioMed does not accept referrals from employment agencies unless written authorization from the Orchestra BioMed Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore Orchestra BioMed will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at Orchestra BioMed.