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Nda Jobs Near Me

Owens Corning

Sr Engineer R & D

Granville, OH

Understand and ensure communication with non-OC contacts is covered under NDA when applicable JOB REQUIREMENTS MINIMUM QUALIFICATIONS : * Advanced degree in Engineering or related Scientific or ...

Owens Corning

Sr Technician

Granville, OH

... NDA when applicable. * Helps to coordinate third party testing as required. Maintain Testing Excellence * Manages day-to-day testing and lab operations, including material flow, inventory, storage ...

Owens Corning

Engineer R & D

Granville, OH

Ensures proper documentation and protection of intellectual property and adherence to NDA requirements. Provides training and support to system users, ensuring high adoption and effective use of ...

Owens Corning

Sr Engineer R & D

Granville, OH · On-site

Understand and ensure communication with non-OC contacts is covered under NDA when applicable JOB REQUIREMENTS MINIMUM QUALIFICATIONS : * Advanced degree in Engineering or related Scientific or ...

EMPIRE

Director, Investment - Central Region

Columbus, OH · On-site

$141K - $200K/yr

Draft and review Letters of Intent, RFP's for BTS Proposals, NDA's/CA's, Joint Marketing Agreements, Purchase & Sale Agreements andJointVentureAgreements. * Cultivate engagement in Prologis ...

Owens Corning

Engineer R & D

Granville, OH · On-site

... NDA requirements. • Provides training and support to system users, ensuring high adoption and effective use of tools • In partnership with leadership defines lab metrics and KPI's relative to ...

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Nda jobs near you
A map of the United States highlighting the number of Nda job openings by state according to ZipRecruiter. The image is accompanied by a detailed chart listing the number of Nda job openings in each state, with California having the most at 2 and Hawaii the least at 0.

Sr. Scientist, Formulation Development

Hikma Pharmaceuticals PLC

Columbus, OH • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 15 days ago

Hikma Pharmaceuticals rating

8.0

Company rating: 8.0 out of 10

Based on 30 frontline employees who took The Breakroom Quiz

43rd of 86 rated pharmaceutical

Job description

Job Title: Sr. Scientist, Formulation Development
Location: Columbus, OH
Job Type: Full time
Req ID: 11881
About Us:
As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our 32 manufacturing plants, three R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.
Description:
We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Sr. Scientist, Formulation Development to join our team.
Hikma is expanding its orally inhaled and nasal drug product (OINDP) capability, and we're looking for a formulation scientist who wants to work on technically demanding, high-impact programs from early development through to regulatory submission and launch. This role sits within our growing OINDP formulation team and will be pitched at level depending on your experience. What matters most is depth of knowledge, scientific rigor, and the ability to work at pace across a commercially oriented pipeline.
Key Responsibilities:
  • Design and execute formulation development studies for OINDPs, applying QbD principles throughout
  • Lead or contribute to CMC sections of regulatory dossiers (ANDA, NDA, 505(b)(2) - formulation development reports, excipient justifications, comparability studies. Draft controlled correspondence and responses to project specific deficiency letters as needed.
  • Characterize formulations using methods relevant to OINDP: particle size, aerodynamic performance (NGI/ACI), spray geometry, viscosity, osmolality, and related physical chemistry
  • Support Bioequivalence strategy development, including, IVIVC, biowaiver arguments, and Q1/Q2/Q3 sameness justifications
  • Analyze and interpret experimental data using relevant tools (e.g. JMP, Minitab, Python, or Excel) to draw clear scientific conclusions, identify trends, and define the next cycle of formulation or process development with confidence
  • Collaborate with device/engineering teams on product-device compatibility and human factors considerations
  • Drive tech transfer and scale-up activities, including work with CDMOs
  • Author and review protocols, batch records, and CMC documentation to GMP/GLP standards. Manufacture developmental and clinical (pilot / registration) batches.

Qualifications:
We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:
  • Bachelor's Degree (Pharmaceutical Sciences, Chemistry, Chemical Engineering) plus a minimum 4 yrs experience with the following:
    • Hands-on OINDP formulation development experience or drug-device formulation is particularly valued. Experience in formulation development of pharmaceutical dosage forms is valued. OR
  • Master's degree (Pharmaceutical Sciences, Chemistry, Chemical Engineering) plus a minimum 2 years of experience with the following:
    • Hands-on OINDP formulation development experience or drug-device formulation is particularly valued. Experience in formulation development of pharmaceutical dosage forms is valued. OR
  • PhD (Pharmaceutical Sciences, Chemistry, Chemical Engineering) plus minimum 1 years of experience with the following:
    • Hands-on OINDP formulation development experience or drug-device formulation is particularly valued. Experience in formulation development of pharmaceutical dosage forms is valued.
  • Working knowledge of ICH guidelines and FDA/EMA expectations for OINDP
  • Experience in working to cGMP and compliance requirements is desirable but not essential.
  • Experience with excipient selection and justification (preservative systems, antioxidants, tonicity agents).
  • Ability to work effectively across formulation, analytical, clinical, QA, operations, IP, and regulatory functions.

Preferred Qualifications:
  • Experience with scale up in GMP environment
  • Experience with regulatory submissions (ANDA / NDA)
  • Knowledge (understanding and interpretation) of analytical characterization techniques
  • Experience with good documentation practices for GMP batches
  • Experience with use of statistical tools in data analysis
  • Knowledge of in-vitro in-vivo correlation

What We Offer*:
  • Annual performance bonus, commission, and share potential
  • Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
  • A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
  • 3 personal days (prorated based on hire date)
  • 11 company paid holidays
  • Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
  • Employee discount program
  • Wellbeing rewards program
  • Safety and Quality is a top organizational priority
  • Career advancement and growth opportunities
  • Tuition reimbursement
  • Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Recruiters:
Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.
Equal Opportunity Employer:
Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
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