Job Description

Job Summary Associate Director, Biologics Drug Product Development oversees the formulation development and fill finish processes for bio-therapeutics, technology transfer to clinical and commercial CDMOs. You should have extensive experience in early and late phase Biologics development and foster productive collaborations with internal QA, Clinical Development and Regulatory teams. You will report to Director, Biologics Development. Job Description You will be subject matter expert in the formulation development for biologics, biophysical characterization studies, drug product process development, tech transfer and process characterization studies. Responsible for strategic oversight and leadership of the full scope of drug product activities for biologics early phase through commercialization. Review and author development reports, comparability protocols, specifications, validation reports and other technical documents for technical correctness and regulatory compliance. A proven track record of technical skills in this area, experience with early and late-stage regulatory filings and regulatory interactions, and experience working effectively with third-party DP CMOs is essential. Work collaboratively with formulation, analytical, quality and regulatory SMEs to develop sound, integrated plans for development and manufacturing. Demonstrate knowledge of drug stability evaluation and mitigation strategies for early and late phase development strategy. Experience in DP development for commercialization including risk assessments, process characterization and validation of combination products. Experience in authoring and reviewing CMC documents for regulatory submission documents (IND, IMPD, BLA, MAA etc.). Provide strategic guidance on regulatory interactions relating to drug product formulation and process development, specifications setting and control strategy. Ensure effective communication, and collaboration, and preparation of dossiers in collaboration with functional CMC leads & external partners. Manage budgets, schedules, and performance requirements to meet project goals. Qualifications/ Required Knowledge/ Experience and Skills: Ph.D preferred in a relevant field (e.g. biochemistry/chemistry, pharmaceutical sciences, chemical engineering) with 10 years, MS with 15 years of experience, or equivalent experience in the biopharmaceutical industry. Ability to work in a fast-paced dynamic environment with changing priorities, forward thinking with flexibility to support multiple development programs simultaneously. Working knowledge of ICH and FDA guidelines and global regulations. Experience with regulatory, QA, and cGMP requirements for biologics. Assist in OOS investigations, determination of root cause, and implementation of appropriate CAPA. Experience with IND and BLA filings; knowledge of relevant FDA regulations and guidelines is required. Track record of successfully driving and managing programs, overcoming challenges, and managing risks. Excellent communication and interpersonal skills in working across the organization. Travel: Up to 25% of the time - occasional international travel to partner and/or contractor facilities related to engineering, GMP and PPQ runs. Competencies Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business. Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders. Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. Empowered Development - Play an active role in professional development as a business imperative. Come discover more about Otsuka and our benefit offerings; . Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer . All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic . If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability . You can request reasonable accommodations by contacting Accommodation Request . Statement Regarding Job Recruiting Fraud Scams At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., a nd Otsuka Precision Health, Inc. (Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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