Product Owner jobs at Navitus - 86 jobs

Company Navitus About Us Navitus - Putting People First in Pharmacy - Navitus was founded as an alternative to traditional pharmacy benefit manager (PBM) models. We are committed to removing cost from the drug supply chain to make medications more affordable for the people who need them. At Navitus, our team members work in an environment that celebrates diversity, fosters creativity and encourages growth. We welcome new ideas and share a passion for excellent service to our customers and each other._____________________________________________________________________________________________________________________________________________________________________________________________________________. Current associates must use SSO login option at ************************************ to be considered for internal opportunities. Pay Range USD $69,627.00 - USD $83,888.00 /Yr. STAR Bonus % (At Risk Maximum) 5.00 - Salaried Non-Management except pharmacists Work Schedule Description (e.g. M-F 8am to 5pm) M-F 8am to 5pm Remote Work Notification ATTENTION: Navitus is unable to offer remote work to residents of Alaska, Hawaii, Maine, Mississippi, New Hampshire, New Mexico, North Dakota, Rhode Island, South Carolina, South Dakota, West Virginia, and Wyoming. Overview Due to growth, we are adding a Product Manager, Innovative Pharmacy Programs to our team! The Product Manager (PM) will be responsible for managing operations for both existing products and new product development for assigned specialty and strategic products. Working under the direction of the Assoc. Director, Innovative Pharmacy Programs, the PM will manage and coordinate the execution for certain Innovative Pharmacy Programs. The PM will oversee day-to-day activities to ensure that the relevant products are fully integrated with the communication and sales plans. The PM leads the process of maintaining and improving the relevant products and contributes to the development of new ones. The individual must work cross-functionally in order to achieve departmental level objectives in support of the strategic plan. Is this you? Find out more below! Responsibilities How do I make an impact on my team? Manage the assigned products through adjusting and optimizing the marketing mix as the products move through the product life cycle Assist in the analysis of product capacity and capabilities for managing new clients Develop a keen understanding of Navitus products in the marketplace in order to work collaboratively to expand product offerings, refine current product positioning and develop key messages for both existing and potential clients Monitor the products performance, position and utility for our clients and their members Apply project management techniques to effectively manage project scope, resources, and timeline for product development initiatives Assure appropriate testing has been conducted for any system/app enhancement or break-fix Ensure products meet all regulatory requirements Other duties as assigned Qualifications What our team expects from you? A minimum of a Bachelor's Degree is preferred Minimum 2 year product management/development or related experience is required Experience in the health, biomedical, or pharmaceutical fields is preferred Participate in, adhere to, and support compliance program objectives The ability to consistently interact cooperatively and respectfully with other employees What can you expect from Navitus? Top of the industry benefits for Health, Dental, and Vision insurance 20 days paid time off 4 weeks paid parental leave 9 paid holidays 401K company match of up to 5% - No vesting requirement Adoption Assistance Program Flexible Spending Account Educational Assistance Plan and Professional Membership assistance Referral Bonus Program - up to $750! #LI-Remote Location : Address Remote Location : Country US

About the Company Satsuma.ai (Formerly MealMe.ai) is building the infrastructure layer that connects merchants to the new world of AI agents and conversational interfaces. As AI systems like ChatGPT, Alexa, and others begin to search, recommend, and transact on behalf of users, Satsuma ensures products are visible, accessible, and monetizable in real time. We partner directly with merchants to make their products and services searchable and orderable by AI. Through our API and Merchant Gateway, we enable real-time access to structured data-like product catalogs, menus, pricing, and availability-while giving merchants full control over access, pricing, and usage through their Merchant Console. Whether it's a grocery chain, restaurant group, or large retailer, Satsuma transforms AI traffic into revenue by routing it through merchant-owned infrastructure. Our platform unlocks two major value streams: high-margin data monetization and increased order volume from AI-native channels. Satsuma is backed by leading investors such as Mercury Fund, Palm Drive Capital, Quiet Capital, Slow Ventures, AIX Ventures, and more. We are growing rapidly as we help merchants own their presence in the era of AI commerce. Responsibilities Develop and articulate the product vision, roadmap, and strategy in line with company objectives. Conduct market research and competitive analysis to identify opportunities and customer needs. Collaborate with cross-functional teams to create detailed product specifications and user stories. Prioritize product features and enhancements based on impact, feasibility, and user feedback. Lead the product development lifecycle, ensuring timely delivery and quality standards are met. Act as the main point of contact for stakeholders and provide updates on product progress and metrics. Requirements Bachelor's degree in Business, Marketing, Computer Science, or a related field. 3+ years of SaaS and/or AI product management experience Proven track record of managing the entire product lifecycle from concept to launch. Strong understanding of agile methodologies and experience working in agile development teams. Excellent analytical skills with the ability to leverage data to drive decisions. Exceptional communication and interpersonal skills, with a knack for building relationships across teams. Passion for innovative technology and a customer-focused mind-set. Benefits Retirement Plan (401k, IRA) Paid Time Off (Vacation, Sick & Public Holidays) Work From Home Free Food & Snacks Wellness Resources Stock Option Plan

Job DescriptionAbout the Company Satsuma.ai (Formerly MealMe.ai) is building the infrastructure layer that connects merchants to the new world of AI agents and conversational interfaces. As AI systems like ChatGPT, Alexa, and others begin to search, recommend, and transact on behalf of users, Satsuma ensures products are visible, accessible, and monetizable in real time. We partner directly with merchants to make their products and services searchable and orderable by AI. Through our API and Merchant Gateway, we enable real-time access to structured data-like product catalogs, menus, pricing, and availability-while giving merchants full control over access, pricing, and usage through their Merchant Console. Whether it's a grocery chain, restaurant group, or large retailer, Satsuma transforms AI traffic into revenue by routing it through merchant-owned infrastructure. Our platform unlocks two major value streams: high-margin data monetization and increased order volume from AI-native channels. Satsuma is backed by leading investors such as Mercury Fund, Palm Drive Capital, Quiet Capital, Slow Ventures, AIX Ventures, and more. We are growing rapidly as we help merchants own their presence in the era of AI commerce. Responsibilities Develop and articulate the product vision, roadmap, and strategy in line with company objectives. Conduct market research and competitive analysis to identify opportunities and customer needs. Collaborate with cross-functional teams to create detailed product specifications and user stories. Prioritize product features and enhancements based on impact, feasibility, and user feedback. Lead the product development lifecycle, ensuring timely delivery and quality standards are met. Act as the main point of contact for stakeholders and provide updates on product progress and metrics. Requirements Bachelor's degree in Business, Marketing, Computer Science, or a related field. 3+ years of SaaS and/or AI product management experience Proven track record of managing the entire product lifecycle from concept to launch. Strong understanding of agile methodologies and experience working in agile development teams. Excellent analytical skills with the ability to leverage data to drive decisions. Exceptional communication and interpersonal skills, with a knack for building relationships across teams. Passion for innovative technology and a customer-focused mind-set. Benefits Retirement Plan (401k, IRA) Paid Time Off (Vacation, Sick & Public Holidays) Work From Home Free Food & Snacks Wellness Resources Stock Option Plan

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud - the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. You will make an impact: At eClinical Solutions, our goal is to empower life sciences organizations around the world to manage and analyze clinical data more efficiently through an AI-first approach. We are looking for a Product Owner who will play a key role in translating customer and business needs into actionable user stories that guide the development of the elluminate platform. You will be a champion of user value and data-driven design, working closely with product managers, engineers, UX designers, and clinical domain experts to shape high-impact product features. This role is ideal for someone who is detail-oriented, passionate about user experience, and thrives in a collaborative, fast-paced agile environment. Your day to day: Translate Strategy into Execution Partner with product managers and stakeholders to break down high-level product strategies into clear, detailed epics and user stories Serve as the voice of the customer in agile ceremonies, ensuring the team is always aligned on delivering business and user value Support creation of wireframes and prototypes to visualize workflows and improve user experience Collaborate with engineering and UX teams to refine requirements, review prototypes, and validate deliverables throughout the sprint cycle Facilitate Agile Collaboration Participate in all agile rituals, including sprint planning, backlog grooming, reviews, and daily standups Maintain a well-prioritized product backlog, ensuring clarity, consistency, and alignment with roadmap goals Collaborate cross-functionally with QA, documentation, services, and support teams to ensure successful product releases Contribute to Market & Domain Intelligence Research and document industry trends, competitive offerings, and evolving customer needs Stay informed on clinical trial standards, data workflows, and regulatory requirements Contribute to knowledge sharing across the organization through release notes, internal trainings, and support materials Education & Experience Bachelor's degree in a life sciences discipline, computer science, or related field, or equivalent work experience preferred 5+ years of experience in a product owner, business analyst, or clinical data role within life sciences technology or clinical trials preferred Hands-on experience with agile product development processes and tools (e.g., Jira, Confluence, ProductBoard) Prior experience working on a cloud-based SaaS platform strongly preferred Professional Skills Strong understanding of product development lifecycle and user-centered design principles Proven ability to write clear, concise user stories and acceptance criteria Excellent communication and interpersonal skills; comfortable presenting ideas and facilitating cross-team discussions Highly organized with strong attention to detail and the ability to manage multiple priorities Curious, analytical mindset with a passion for solving real-world problems in clinical research Technical & Domain Skills Familiarity with clinical trial workflows, EDC systems, and regulatory standards (e.g., CDISC, 21 CFR Part 11, IHC E6) is a plus Experience creating or reviewing clinical metadata and working with data visualization tools is desirable Working knowledge of agile methodologies and best practices for backlog management Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours! eClinical is a winner of the 2023 Top Workplaces USA national award! We have also received numerous Culture Excellence Awards celebrating our exceptional company vision, values, and employee experience. See all the details here: ****************************************************** eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here! We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need. #LI-AB1 Pay Range US Pay Ranges $100,000-$120,000 USD

Requisition ID: 63705 Title: Clinical Product Manager - Global Endoscopy Division: Arthrex, Inc. (US01) Location: Remote Salary Range: Salary Minimum: $94,500 Salary Maximum: $170,000 This position is remote, with travel primarily to West Coast. The ideal candidate will be based in the Western US. Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Clinical Product Manager to manage and lead our initiatives within the Global Endoscopy portfolio. The successful candidate will build relationships with key customers and internal departments to help drive new product innovation and manage product lines. Excellent interpersonal and leadership skills along with a Bachelor's degree and five years of experience are essential for this position. The position is remote to be based in our West coast or Northeast regions and does require frequent travel. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better. Main Objective: The Clinical Product Manager will be responsible for overseeing and managing the Multi-specialty imaging solution - focusing on fluorescence and additional visualization modalities sales opportunities, performance, training, and other activities with the sales force, surgeons, and accounts within his/her respective region. In addition, candidate is expected to forge new relationships with bio science partners focused on advanced visualization. Essential Duties and Responsibilities: * Ensure all IR Managers are trained to a high standard on anatomy, procedures and fluorescence science. * Manage clinical studies/research papers related to fluorescence imaging. * Assist IR Managers, Capital Managers & representatives with evaluation and closing activities with key customers and reporting back to Imaging and Resection Managers as it relates to advanced visualization. * Training representatives on advanced visualization and fluorescence solutions and sales cycle as needed. * Assist Imaging and Resection Sales Management in implementing sales playbook and execution of strategy. * Lead interaction with General, Urology, GYN, ENT and Thoracic surgeons to expand brand awareness of the Synergy solutions. Assist Ortho surgeons in fluorescence imaging discovery. * Manage entire sales pipeline to monitor health of the business and maximize closure rate and success. * Communicate sales opportunities to the Director - Global Endoscopy, Imaging and Resection Sales Management and Product Management. * Communicating product attributes and shortcomings to product managers and recommending product line enhancements. * Collecting key competitive information and ensuring that knowledge drives both sales effectiveness and product development direction. * Coaching, teaching, and when necessary directing opportunities to via conference calls and in person visits on products/sales strategy/competitive info. * Engage current and identify new Key Opinion Leaders for Local, Regional, and national peer to peer interactions. * Lead the submittal of RFP and tender responses working with regional and agency sales managers. * Up to 60% Travel. Education and Experience: * Bachelors degree required; MBA preferred. * Five years medical device sales or product management experience required, preferably in laparoscopic surgery. * Experience in the field with Endoscopy insufflation and fluorescence in Sales/Marketing required. * Experience at C-Suite level negotiations required. Knowledge and Skill Requirements/Specialized Courses and/or Training: * Willing to travel up to 60 % to sales presentations, trials, evaluations, demos, tradeshows, and customer meetings. * Knowledge of advanced surgical video and integration. * Skilled in working with different functions and effectively coordinates their activities to achieve desired results. * Excellent listening skills, including the ability to identify and isolate customers concerns or objections, in addition to excellent written and oral communication skills. * Strong relationship building skills desired. Arthrex Benefits * Medical, Dental and Vision Insurance * Company-Provided Life Insurance * Voluntary Life Insurance * Flexible Spending Account (FSA) * Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness) * Matching 401(k) Retirement Plan * Annual Bonus * Wellness Incentive Program * Gym Reimbursement Program * Tuition Reimbursement Program * Trip of a Lifetime * Paid Parental Leave * Paid Time Off * Volunteer PTO * Employee Assistance Provider (EAP) All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law. Making People Better at Arthrex Lorem ipsum dolor sit amet consectetur. Cras fringilla elementum odio velit. Job Details Date: Dec 15, 2025 Requisition ID: 63705 Salary Range: Job title: Clinical Product Manager - Global Endoscopy Arthrex Location: Remote, US, 34108 Nearest Major Market: Naples Job Segment: Product Manager, Gastroenterology, Medical Research, Clinic, Operations, Healthcare, Marketing

SummaryJob Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health ™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. About the role: In this role you will partner with the product owner on projects, and the overall cross-functional team, to support the successful global launch of a key initiative for bdbiosciences.com. You will lead projects aimed at improving customer experience through the eBusiness channel including web, e-commerce, B2B, punchout and other digital channels. You will also support the team that leads multiple related but distinct projects, with members of marketing, IT, shared services (legal, regulatory, etc.), and external vendors to ensure seamless execution of all phases through launch. Key responsibilities include: Works with product owner and other functional leaders to ensure the appropriate core team resources and the external strategic partners are committed to the projects and supply to the expected levels. Develops detailed program/project execution plan, and manages implementation processes including financials, progress tracking, metrics, monitoring change control process, testing, release to production and on-time delivery within budget constraints. Provides overall communication and works with all areas affected by the program/project. Drives the team to project completion ensuring that we are creating best-in-class product and service experiences. Coordinates cross-team dependencies or participate in Scrum of Scrums, if applicable. Provides regular status updates, dashboards, and reports to leadership. Improves project workflows, documentation, and team productivity. Identifies opportunities for automation, process optimization, and better team coordination. Facilitates all scrum ceremonies: Daily Stand-ups, Sprint Planning, Sprint Review, and Sprint Retrospective. Ensures Scrum events are efficient, valuable and time-boxed. Facilitates coordinate and track UAT for major enhancements and projects. Builds a safe and trustful environment with an emphasis on problem-solving and psychological safety. About you: To succeed in this role, someone needs to be highly organized and skilled at managing complex projects across multiple teams, with strong communication and collaboration abilities. They should be comfortable working in an Agile environment as a Scrum Master, able to remove obstacles, keep projects on track, and ensure seamless execution. A focus on customer experience and digital solutions is essential, along with adaptability to handle competing priorities in a fast-paced global setting. Required education and experience Bachelor's degree in computer science, Engineering, Information Systems, or related field First or second level Scrum Master (CSM, ACSM, PSM I/II) or Certified Scrum Professional (CSP) At least 4 years of experience in technical project management, program management, or related technical roles Expert-level knowledge of JIRA and Confluence, with the ability to customize them based on project needs Experience working with Agile, Scrum, or Kanban methodologies. Experience with Agile traits and techniques: Lean design, accommodating changing requirements, iterations, loop feedback with customer involvement. Demonstrated consistent ability to lead cross-functional teams and deliver technical solutions while mitigating or removing hurdles / obstacles. Proven a track record of overcoming project crisis. Ability to lead cross-functional leadership in a global, fast-paced, matrix organization. Strong analytical and problem-solving skills. Preferred qualifications: Ecommerce experience highly preferred Technical knowledge preferred At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. --- Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of our health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA CA - Milpitas 155Additional LocationsWork Shift At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You. Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others. Position Summary: This position will report to the Senior Director of Drug Product Development and will be managing the activities related to preformulation, biopharmaceutics, formulation development from Phase 1 to commercial launch. This individual will be an integral part of the company's effort to discover and develop therapeutics for rare endocrine disorders and endocrine-related tumors. Essential Job Functions and Responsibilities: These may include but are not limited to: Integrate biopharmaceutics principles to guide drug product design and development, ensuring clinically meaningful formulation strategies. Design and develop formulation and processes to enable clinical studies with the desired performance. In collaboration with DMPK and Clinical Pharmacology, develop and apply advanced modeling-informed strategies (e.g., PBPK) to predict drug dissolution, absorption, bioavailability, enabling formulation optimization, bridging decisions, and risk mitigation. Design and execute experiments for development of rational, scientifically sound, phase appropriate formulations and manufacturing processes including biorelevant conditions to simulate in vivo performance. Utilize software tools such as GastroPlus to model gastrointestinal physiology and inform formulation decisions. Apply deep understanding of physiological factors (e.g., GI pH, transit times, regional absorption) to interpret human and animal clinical data, linking dissolution behavior to in vivo drug performance and guiding formulation refinement. Contribute biopharmaceutics expertise to regulatory submissions, including IVIVC (In Vitro-In Vivo Correlation) and MIDD (Model-Informed Drug Development). Stay current with advancements in predictive modeling, dissolution testing methodologies, and regulatory requirements. Plan, direct, and oversee formulation, process development, manufacturing, and packaging activities at contract development and manufacturing organizations (CMOs). Evaluate and select external partners for drug product development and manufacturing. Prepare Drug Product development and manufacturing timelines and set clear deliverables for projects Prepare and review request of proposal (RFPs), statements of work (SOWs), and associated budgets. Prepare and review regulatory filings (IBs, INDs, IMPDs, NDAs, briefing packages). Author and review SOPs, technical reports, specifications, CAPAs, change controls, investigations, and deviations to ensure compliance with cGMP and company standards. Education and Experience: Required: A PhD in Pharmacokinetics, Pharmaceutical Science, or a related field with at least 7 years of related technical experience in the small molecule biopharmaceutical industry. Experience supporting regulatory submissions with biopharmaceutics expertise. Expertise in PBPK modeling and pharmacokinetics, with proficiency in software tools such as GastroPlus, Phoenix WinNonlin, and Simcyp. Strong knowledge of dissolution testing methodologies and ability to design experiments with accurate testing conditions. Experience in applying biopharmaceutics principles to late-stage drug development and formulation optimization. Familiarity with FDA, EMA, and ICH guidelines related to biopharmaceutics and predictive modeling. Lead work experience in drug product development and clinical manufacturing for small molecules. Understanding of cGMP requirements and ICH and regulatory guidance is preferred. Excellent analytical, problem-solving, and communication skills. Physical Demands and Work Environment: Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply. Travel: Travel may be required up to 15% of your time. Equal Opportunity Employer: Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws. Total Compensation: The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process. Salary Range The salary range for this position is: $154,000 - $192,000. In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others. Position Summary: This position will report to the Senior Director of Drug Product Development and will be managing the activities related to preformulation, biopharmaceutics, formulation development from Phase 1 to commercial launch. This individual will be an integral part of the company's effort to discover and develop therapeutics for rare endocrine disorders and endocrine-related tumors. Essential Job Functions and Responsibilities: These may include but are not limited to: * Integrate biopharmaceutics principles to guide drug product design and development, ensuring clinically meaningful formulation strategies. * Design and develop formulation and processes to enable clinical studies with the desired performance. * In collaboration with DMPK and Clinical Pharmacology, develop and apply advanced modeling-informed strategies (e.g., PBPK) to predict drug dissolution, absorption, bioavailability, enabling formulation optimization, bridging decisions, and risk mitigation. * Design and execute experiments for development of rational, scientifically sound, phase appropriate formulations and manufacturing processes including biorelevant conditions to simulate in vivo performance. * Utilize software tools such as GastroPlus to model gastrointestinal physiology and inform formulation decisions. * Apply deep understanding of physiological factors (e.g., GI pH, transit times, regional absorption) to interpret human and animal clinical data, linking dissolution behavior to in vivo drug performance and guiding formulation refinement. * Contribute biopharmaceutics expertise to regulatory submissions, including IVIVC (In Vitro-In Vivo Correlation) and MIDD (Model-Informed Drug Development). * Stay current with advancements in predictive modeling, dissolution testing methodologies, and regulatory requirements. * Plan, direct, and oversee formulation, process development, manufacturing, and packaging activities at contract development and manufacturing organizations (CMOs). * Evaluate and select external partners for drug product development and manufacturing. * Prepare Drug Product development and manufacturing timelines and set clear deliverables for projects * Prepare and review request of proposal (RFPs), statements of work (SOWs), and associated budgets. * Prepare and review regulatory filings (IBs, INDs, IMPDs, NDAs, briefing packages). * Author and review SOPs, technical reports, specifications, CAPAs, change controls, investigations, and deviations to ensure compliance with cGMP and company standards. Education and Experience: Required: * A PhD in Pharmacokinetics, Pharmaceutical Science, or a related field with at least 7 years of related technical experience in the small molecule biopharmaceutical industry. * Experience supporting regulatory submissions with biopharmaceutics expertise. * Expertise in PBPK modeling and pharmacokinetics, with proficiency in software tools such as GastroPlus, Phoenix WinNonlin, and Simcyp. * Strong knowledge of dissolution testing methodologies and ability to design experiments with accurate testing conditions. * Experience in applying biopharmaceutics principles to late-stage drug development and formulation optimization. * Familiarity with FDA, EMA, and ICH guidelines related to biopharmaceutics and predictive modeling. * Lead work experience in drug product development and clinical manufacturing for small molecules. * Understanding of cGMP requirements and ICH and regulatory guidance is preferred. * Excellent analytical, problem-solving, and communication skills. Physical Demands and Work Environment: Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply. Travel: Travel may be required up to 15% of your time. Equal Opportunity Employer: Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws. Total Compensation: The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process. Salary Range The salary range for this position is: $154,000 - $192,000. In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **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. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. 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 (EEAccommodations@otsuka-us.com) . **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: ************. 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., and 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.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **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. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. 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 (EEAccommodations@otsuka-us.com) . **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: ************. 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., and 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.

We are seeking a Senior Technical Product Lead to drive product and project leadership within a drug product contract manufacturing organization (CMO). This role supports programs from initial facility fit assessment and technology transfer through client interaction, process improvements, validation, and commercial manufacturing. The Technical Product Lead will be part of the MS&T (Manufacturing Science & Technology) group, leading client interactions, internal project management, and technical and business process improvements. This position is fully on-site at our facility in Costa Mesa, CA. Key Responsibilities: New Product Introduction: Lead and contribute to proposal writing and review. Conduct facility fit assessments for new manufacturing programs, including risk assessments, failure mode analyses, and process impact evaluations. Oversee technology transfer activities between development and manufacturing. Translate process development reports into manufacturing batch records and SOPs. Provide hands-on manufacturing process training as part of technology transfer. Project Management: Develop and lead process improvement projects. Implement systems for improved GMP planning, scheduling, and execution. Oversee the lifecycle management of clinical and commercial programs. Develop and manage comprehensive project plans, sharing key deliverables with internal and external stakeholders. Serve as a primary client liaison, ensuring high-quality contract manufacturing services. Act as a technical interface between internal teams and client partners. Quality & Compliance: Support root cause investigations and CAPA (Corrective and Preventive Actions) implementation. Author and manage change control for internal and client-related projects. Drive operational excellence in collaboration with Manufacturing by identifying and implementing process improvements. Qualifications: Bachelor's Degree in Sciences or Engineering or equivalent experience. 8 years of experience supporting biotech or pharmaceutical manufacturing operations. Experience with aseptic operations and drug product manufacturing is required. 5 years of experience in project management within a biotech, pharmaceutical, or CMO setting. Strong understanding of GMP regulations and compliance within manufacturing facilities. Ability to analyze and improve manufacturing process data. Excellent written and verbal communication skills (technical writing ability required). Ability to work cross-functionally within internal and external teams to drive project success. Self-motivated, adaptable, and comfortable in a fast-paced contract manufacturing environment. Able to manage multiple projects simultaneously, ensuring on-time delivery and customer satisfaction.

Job Description We are seeking a Senior Technical Product Lead to drive product and project leadership within a drug product contract manufacturing organization (CMO). This role supports programs from initial facility fit assessment and technology transfer through client interaction, process improvements, validation, and commercial manufacturing. The Technical Product Lead will be part of the MS&T (Manufacturing Science & Technology) group, leading client interactions, internal project management, and technical and business process improvements. This position is fully on-site at our facility in Costa Mesa, CA. Key Responsibilities: New Product Introduction: Lead and contribute to proposal writing and review. Conduct facility fit assessments for new manufacturing programs, including risk assessments, failure mode analyses, and process impact evaluations. Oversee technology transfer activities between development and manufacturing. Translate process development reports into manufacturing batch records and SOPs. Provide hands-on manufacturing process training as part of technology transfer. Project Management: Develop and lead process improvement projects. Implement systems for improved GMP planning, scheduling, and execution. Oversee the lifecycle management of clinical and commercial programs. Develop and manage comprehensive project plans, sharing key deliverables with internal and external stakeholders. Serve as a primary client liaison, ensuring high-quality contract manufacturing services. Act as a technical interface between internal teams and client partners. Quality & Compliance: Support root cause investigations and CAPA (Corrective and Preventive Actions) implementation. Author and manage change control for internal and client-related projects. Drive operational excellence in collaboration with Manufacturing by identifying and implementing process improvements. Qualifications: Bachelor's Degree in Sciences or Engineering or equivalent experience. 8 years of experience supporting biotech or pharmaceutical manufacturing operations. Experience with aseptic operations and drug product manufacturing is required. 5 years of experience in project management within a biotech, pharmaceutical, or CMO setting. Strong understanding of GMP regulations and compliance within manufacturing facilities. Ability to analyze and improve manufacturing process data. Excellent written and verbal communication skills (technical writing ability required). Ability to work cross-functionally within internal and external teams to drive project success. Self-motivated, adaptable, and comfortable in a fast-paced contract manufacturing environment. Able to manage multiple projects simultaneously, ensuring on-time delivery and customer satisfaction.

A245 - 4B The Senior Product Marketing Manager is responsible for developing and executing marketing strategies for assigned products to drive product performance, market share, and profitability. This role requires a deep understanding of the pharmaceutical market, including the commercialization process, pricing strategies, payor access strategies, and the management of products through various lifecycle stages. The individual will translate scientific and clinical data into compelling marketing plans and work closely with cross-functional teams such as Sales, Payor Access, Patient Services, Regulatory, Legal and Medical Affairs to ensure compliance and alignment with corporate goals. This role as a member of the Portfolio Strategy Marketing team will require contributions and leadership to annual integrated business plan development with associated product forecasts, OPEX and commercial strategies to achieve annual business objectives. Incorporating payor access information with specific data-driven account information and marketing dynamics will be critical to the development of marketing segmentation strategies for tactical investment. ** This is a remote position. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Essential Duties & Responsibilities Strategy Development: Design and implement comprehensive brand marketing strategies for assigned product(s), ensuring that strategies align with business objectives and defined market and channel opportunities. Life Cycle Management: Manage product(s) throughout their lifecycle, from market introduction through maturity and potential loss of exclusivity, ensuring continuous optimization of market performance, profitability, and competitive positioning. Identification of new indications, new business channels or new formulations is very important. Pricing Strategy & Market Access: Collaborate with Market Access to develop pricing strategies consistent with the brand value proposition & key stakeholder dynamics. Manage the P&L including pricing with a focus on maintaining profitable market access. Market Research & Competitive Intelligence: Conduct ongoing market research, competitor analysis, and customer insights to inform product positioning and strategy adjustments. Monitor changes in market trends, competitor product launches, and regulatory changes. KOL & Physician Engagement: Develop and maintain relationships with Key Opinion Leaders (KOLs) and physician advocates to support brand messaging, clinical differentiation, and overall product success. Oversee the organization of advisory boards, speaker programs, and educational symposia in collaboration with Medical Affairs, Legal and other key commercial disciplines. Digital and Multi-Channel Marketing: In collaboration with the Marketing Execution team, drive the implementation of digital and multichannel marketing strategies, including social media, email marketing, and online advertising to enhance product visibility and engagement with healthcare professionals. Product Forecasting & Budget Management: In collaboration with rare disease commercial disciplines and leadership, lead the creation of annual revenue forecasts with key demand assumptions. Ensure knowledge of and ability to make investment decisions in alignment with P&L management. Collaborate with finance teams to optimize budget allocation across marketing activities. Cross-Functional Collaboration: Act as the brand lead and work collaboratively with internal teams such as Marketing Execution, Medical, Regulatory, Legal, Patient Services, and Sales to ensure successful product commercialization and delivery to market. Vendor Management: Oversee the selection and management of external vendors for marketing research, creative agencies, digital marketing, and promotional activities. Ensure projects are delivered on time, within budget, and aligned with strategic objectives. Performance Tracking & Adjustments: Monitor product performance metrics such as sales, market share, and profitability. Adjust marketing plans and tactics based on real-time data and market conditions to maximize brand success. The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. Experience Type Bachelor's degree in with a business concentration (Marketing, Finance) or in health sciences. An MBA is preferred. Minimum 8 years of professional marketing experience ideally within the pharmaceutical industry. Medical device and diagnostic experience would also be considered. Previous experience in payor access / channel marketing or other commercial disciplines. Demonstrated success in leading the development of integrated brand business strategies across commercial disciplines. Previous pharmaceutical launch experience. Strong strategic marketings skills with demonstrated ability to translate clinical data into multi-channel messaging anchored to the brand positioning statement. Ability to develop insights from secondary data, primary research and qualitative information to support alignment on commercial strategic options. Strong interpersonal skills and the ability to work with individuals across all organizational levels - with the ability to articulate thoughts clearly and concisely in writing and through presentations. Previous experience influencing cross-functional teams and mentoring team members in a marketing capacity. Excellent organizational skills and the ability to work on multiple projects simultaneously while under pressure. Proficient with Microsoft Office and familiar with software products pertaining to market analysis (IQVIA), data analysis and reporting. Other Knowledge, Skills and Abilities Understands the commercial and public sector payor landscape, including the impact of formularies, pricing and reimbursement strategies and the need for a concise brand value proposition to support product commercialization. Excellent communication and leadership skills with the ability to influence cross-functional teams and external stakeholders. Analytical mindset with the ability to derive insights from data and make strategic adjustments to improve product performance. Knowledge of digital marketing, CRM systems, and multi-channel marketing strategies to engage healthcare professionals and patients effectively. Strong project management skills, including experience managing budgets, timelines, and external vendors. Experience working in rare disease. Travel up to 25%. Compensation Range: $121,954.00 - $182,931.00 Upsher-Smith Laboratories, LLC is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.

Pharma Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with a mission to develop inhaled drug/biologic and device combination that will transform the standard of care for acute and critically ill patients. Our goal is to create medically superior, proprietary and commercially differentiated combination products by combining proven therapeutic molecules with a unique, high-performance aerosol delivery system. We are embarking on an exciting and dynamic stage in our combination product development, moving into phase 3 clinical trial for one of the biggest breakthroughs in Neonatal care. We are a team of passionate industry experts who are leading, shaping, and driving a potentially transformative medical breakthrough for the treatment of neonatal respiratory distress syndrome (RDS) in the developed world. Additionally, in partnership with The Bill & Melinda Gates Foundation, we have an ambitious program in development to bring low-cost surfactant to the millions of premature babies with RDS born each year. Join us as we embark on this breakthrough and become inspired to deliver. What is the role? The Associate Director of Product Development is a critical role in Aerogen Pharma that will be responsible for key aspects of pharmaceutical development of AeroFact (biologic surfactant) or Synthsurf (Synthetic surfactant). The role will focus on phase appropriate product development of surfactant lyophilized formulations, manufacturing process optimization and scale up, and product characterization supporting pre-clinical and clinical studies. This position will play a central role in establishing and operating Aerogen Pharma's in-house development laboratory. The Associate Director will lead hands-on formulation and process development of lipid/peptide formulations, including design, execution, and iteration of experiments. The role requires expertise with lipid-based formulations, lyophilization, protocol development, and cross-functional experimental execution in collaboration with process engineers, analytical scientists, and lab technicians. Once formulations are developed, the Associate Director will conduct product understanding and characterization studies and lead scale-up and technology transfer to CDMOs. What are the key responsibilities? • Leadership & Strategy: Oversee product development for biologics, proteins, and peptides, managing projects with CDMOs. Develop and execute strategies aligned with Aerogen Pharma's mission and regulatory standards. • In-House Laboratory Development: Establish and manage a formulation/process development laboratory. Design and execute protocols, perform hands-on formulation and process development, including homogenization and lyophilization of lipid/peptide formulations, and coordinate iterative experimental work with a cross-functional team. • Product Development: Research, design, and execute controlled experiments, with high attention to detail to develop stable and effective drug products fit for commercialization. Conduct QbD experiments to identify CQAs that impact product performance and stability. Conduct registration-enabling stability studies and product characterization studies per appropriate ICH guidances. • Product Understanding & Characterization: Lead detailed product characterization studies once lead formulations are developed, ensuring comprehensive product knowledge prior to scale-up. • CDMO/CMO Collaboration: Serve as the primary liaison with external manufacturing and analytical partners. Ensure effective communication and coordination to meet project timelines and quality expectations. • Scale-Up & Tech Transfer: Translate laboratory-developed formulations into scalable processes, overseeing transfer to CDMO partners. • Regulatory Compliance: Prepare and review documentation for regulatory submissions (INDs, BLAs, NDAs). Ensure adherence to cGMP and regulatory requirements. Experience authoring late-stage regulatory dossiers, particularly BLAs, is required. • Cross-Functional Collaboration: Work closely with R&D, Manufacturing, Regulatory, and Quality Assurance teams to integrate product development within overall project goals. • Troubleshooting & Problem Solving: Address and resolve formulation, process optimization, and analytical issues during development and manufacturing. Implement corrective and preventive actions as needed. What education and experience are required? • Ph.D. in Pharmaceutical sciences, Chemical engineering, Biochemical engineering or related field. • 8-10 years in lipid formulations, liposomes, or related drug delivery technologies. • Hands-on experience in formulation and process development, including homogenization and lyophilization. • 2-5 years of manufacturing process development (lyophilization) is a plus. • Extensive experience working with CDMOs is required. • Late-stage product development experience is required. • Experience authoring CMC dossiers for FDA, EMA, and other regulatory agencies is a must. • Knowledge and experience in drug-device development, inhalation drug delivery is a plus. • Knowledge of Good Manufacturing Practices, ICH, FDA, Health Canada, and MHRA Regulations is required. • Excellent written and oral communication skills. What key skills will make you great at the role? • Technical Expertise: Strong hands-on formulation and process development skills, including homogenization and lyophilization. Experience with lipid-based products (including peptides / proteins) is required. Experience with lyophilization manufacturing process development and validation is preferred. • Scientific Rigor: Ability to design, execute, and iterate experimental protocols, interpret data, and guide cross-functional teams to advance development. • Regulatory Knowledge: Deep understanding of regulatory requirements and submission processes for IND and NDA/BLA. • Leadership Skills: Proven ability to establish and lead lab operations, manage and mentor multidisciplinary teams, and foster effective cross-functional collaboration. • Results-Oriented: Strong initiative, accountability, and willingness to take ownership and drive projects to completion. Work independently with CDMOs without close supervision. • Collaboration: Proven ability to operate effectively across a matrix organization to drive programs according to timelines; ability to articulate project objectives and priorities. • Dynamic Thinking: Sense of urgency and a bias toward action; comfortable challenging the status quo and pushing teams to examine all angles. • Communication: Strong written and oral communications skills. • Problem-Solving: Strong analytical skills with a proven track record of overcoming complex scientific challenges. Why Aerogen Pharma As a key member of Aerogen Group, the global market leader in high performance aerosol drug delivery, Aerogen Pharma is at a pivotal point in the company's life cycle. With plans to expand and centralize our US hubs over the next two years, we offer an environment where you can thrive professionally and learn from driven industry leaders in drug development and commercialization, inhaled devices, and neonatology. We foster an inclusive culture that empowers you to contribute to the transformation of Neonatal care, where potential is recognized, and professional development is encouraged.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **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. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. 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 (EEAccommodations@otsuka-us.com) . **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: ************. 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., and 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.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **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. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. 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 (EEAccommodations@otsuka-us.com) . **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: ************. 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., and 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.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **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. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. 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 (EEAccommodations@otsuka-us.com) . **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: ************. 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., and 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.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **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. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. 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 (EEAccommodations@otsuka-us.com) . **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: ************. 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., and 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.

At PriorityPet, our goal is to make an impact on the health and wellness of pets in the community. In fact, our Core Values are (quite literally) written with PETS in mind: Passion, Engagement, Trust and Service. We pride ourselves on maintaining a culture of open communication and collaboration to deliver innovative solutions in today's ever-changing veterinary environment. Together, we want to partner with veterinarians to help build a network of Urgent Care practices across the country - tell us where you want to build your practice, and we will provide you with the full support to make it happen for $0 out-of-pocket. This is your chance to become a practice owner without any of the headache! Job Description We are seeking talented and entrepreneurial Veterinarians to partner with us and become Medical Directors in a practice that we will build together. We're offering immediate ownership/equity opportunities with no out-of-pocket cost! We will provide you with a brand-new building and the state-of-the-art equipment needed to allow you to deliver world-class medicine. Location is completely flexible - let us know where you want to build! This is a prime opportunity to take the next step in your career; become a practice owner and as leader in your hospital, build the culture that you have always envisioned. Most importantly, we emphasize and provide medical autonomy to all our practices since you are the experts in medicine. Our role is to provide the business support and solutions to help you, and your practice, succeed. To learn more about us, please visit our website at ********************************* We offer our Veterinarians: * Competitive compensation with generous performance bonuses * Ownership/Equity opportunities with no out-of-pocket cost * Comprehensive Benefits (100% employer paid medical premiums, liability coverage, paid licensing/fees including DEA, CE allowance, employee assistance program & VIN membership. Optional enrollment in Dental, Vision, Life, 401K w/ company match, pet care discounts and more!) * Student Loan and Relocation Assistance * PTO, parental leave, and company holiday package * Work-life balance, Flexible Scheduling and no overnights: We are family friendly, and your mental health is important to us. We appreciate the importance of maintaining a healthy life outside of our work family * DVM Mentor Network Qualifications * Doctorate in Veterinary Medicine (or equivalent) from an accredited university, and an active veterinary state license * 3+ Years of Veterinarian Experience * Current DEA License/USDA Accreditation or obtained upon hire * Compassionate leader with the experience and willingness to manage a team and promote a positive clinic culture as it aligns with Alliance Animal Health's core values * Effective communicator with a drive to provide the highest quality medicine and mentor other veterinarians to do so as well Additional Information We offer our Veterinarians: Flexible Scheduling Comprehensive Benefits (paid vacation/sick time/holidays, health, dental, vision, liability, 401K, life & supplemental insurance, employee assistance program & personal pet care discounts) Future Ownership/Equity Opportunities Competitive Compensation Medical Autonomy DVM Mentor Network Paid CE Allowance & Professional Dues