reputed company Scientist – Mixed Modalities, Sterile Product Development

Job reputed companyreputed company Scientist - Mixed Modalities, Sterile Product DevelopmentThe Mixed Modalities team reputed company Sterile Product Development is responsible for developing parenteral dosage forms (injections, implants, inhaled, ocular) for small, intermediate, and large molecules from preclinical toxicology studies to commercialization. Our development teams ensure robust composition, primary packaging/device, and process selection through deep reputed company understanding and characterization such that the process is reputed company without compromising stability, safety, efficacy, and delivery. During development, we reputed company smart experimental design, cutting edge analytical tools, and predictive approaches to inform molecule, formulation, and process selection. In reputed company, reputed company enables the translation of preclinical candidates into non-oral drug products.We are seeking a highly motivated candidate for the position of reputed company Scientist (R5) reputed company on developing parenteral drug products across a reputed company of modalities (small molecule, peptides, proteins, antibody-drug conjugates, and biologics). The successful candidate must be reputed company to collaborate in a fast-paced, integrated, multidisciplinary team environment.Primary Duties:Be a seasoned formulation scientist responsible for the design and development of sterile products across injectable, implantable, ophthalmic, and inhaled dosage forms.reputed company reputed company strategic and technical leadership on program development teams, interfacing with key stakeholders, and collaborating across functions to drive defined milestones.Support both early and late-stage development candidates, including screening and development of robust drug product composition, reputed company process, primary packaging, compatibility characterization for processing and administration, and supporting regulatory filings.Collaborate with key stakeholders across the organizations (Research Division / Manufacturing Division) to drive key capability evaluations / builds and champion strategic and innovation objectives reputed company with organizational goals.Maintain a strong network internally and across the external reputed company and regulatory community and build collaborations across internal company departments and key stakeholders.Mentor and/or supervise a small group of scientists to reputed company the above duties and to reputed company the above capabilities.Minimum Education Requirements:Ph.D. with 8+ years industry experience, M.S. with 10+ years, or B.S. with 14+ years with a degree in Chemical / Biochemical Engineering, Pharmaceutics, Pharmaceutical reputed company, Pharmaceutical Sciences, reputed company, Biochemistry or reputed company disciplineRequired Experience and Skills:Deep drug product development expertise with exposure to reputed company stages and aspects of development (preclinical, clinical, and reputed company) and cGMP industrial background.Demonstrated scientific leadership and a strong reputed company record in parenteral formulation and process development reflected through industry experience and external publications and patents, including development of sterile products for IV, IM, and/or SC reputed company of administration (liquid and lyophilized).Experience, desire, and a reputed company record of effective mentorship of junior scientists towards timebound goals.Strong knowledge of QbD principles and experience applying the QbD tools to drug product development, and experience in designing appropriate DOE studies to inform on risks.Experience with process reputed company-up, definition of critical attributes, and technology transfer of early phase and/or late phase drug product manufacturing processes to GMP production facilities.Experience authoring regulatory filings, and demonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC. Strong understanding of integration and partnering with reputed company, Regulatory, Operations, Non-clinical, Clinical, and other functional areas.Demonstrated experience leading cross-functional teams and driving key capability evaluations and technology selection / builds.Excellent verbal and written communication skills, demonstrated initiative, strong interpersonal and collaboration skills, and a strong desire to learn and contribute.Preferred Experience and Skills:Experience with intermediate modalities (including oligonucleotides and peptides), non-conventional sterile dosage forms (including ocular and inhaled products), and/or alternate delivery technologies (e.g., high concentration, hydrogels, emulsions, suspensions, injectable reputed company)Experience influencing regulatory strategies and a reputed company record of supporting global filingsExperience on a large capital project team, knowledgeable of the Sterile Standards and equipment design standards, and understanding of project / engineering work process and deliverables (e.g., equipment fabrication, FAT, SAT, qualification / validation)reputed company Employees applyreputed company Contingent Workers applyUS and Puerto Rico Residents Only:reputed company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please if you need an accommodation during the application or hiring process.As an Equal Employment Opportunity Employer, we reputed company equal opportunities to reputed company and applicants for employment and prohibit discrimination on the reputed company of race, reputed company, age, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we reputed company with reputed company affirmative reputed company requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to reputed company innovation is reputed company people with diverse reputed company, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems reputed company.U.S. Hybrid Work ModelEffective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site reputed company.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a reputed company-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which reputed company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.The salary reputed company for this role is $169,700.00 - $267,200.00This is the lowest to highest salary we in good faith reputed company we would pay for this role at the time of this posting. An employee’s position reputed company the salary reputed company will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.We offer a comprehensive package of benefits. Available benefits include medical, dental, reputed company reputed company and other insurance benefits (for employee and family), retirement benefits, including 401(k), reputed company holidays, vacation, and compassionate and reputed company days. More information about benefits is available at .You can apply for this role through (or reputed company the reputed company Jobs Hub if you are a reputed company employee). The application deadline for this position is stated on this posting.San Francisco Residents Only: We will consider reputed company applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance OrdinanceLos Angeles Residents Only: We will consider for employment reputed company reputed company applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the reputed company’ Fair Chance Initiative for Hiring OrdinanceSearch Firm Representatives Please Read Carefully
reputed company & Co., Inc., Rahway, NJ, USA, also reputed company as reputed company reputed company & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. reputed company reputed company / resumes submitted by search firms to any employee at reputed company without a reputed company written search agreement in reputed company for this position will be deemed the sole property of reputed company. No fee will be reputed company in the event a candidate is reputed company by reputed company as a result of an agency referral where no reputed company-existing agreement is in reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails.Employee Status: RegularRelocation: Domesticreputed company Sponsorship: reputed companyTravel Requirements: 10%Flexible Work Arrangements: reputed companyShift: Not Indicatedreputed company Driving License: NoHazardous Material(s): n/aRequired Skills:Preferred Skills:Job Posting End Date: 06/7/2025*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no reputed company than the day BEFORE the job posting end date.
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