Organizational Development Specialist, Sr. jobs in New Brunswick, NJ

Organizational Development Specialist, Sr. analyzes organizational structures, responsibilities, team work, business or operating procedures, reporting relationships and work processes to design efficient methods of accomplishing work. Requires a bachelor's degree in a related area and 2-4 years of experience in the field or in a related area. Being an Organizational Development Specialist, Sr. is familiar with standard concepts, practices, and procedures within a particular field. Relies on limited experience and judgment to plan and accomplish goals. Additionally, Organizational Development Specialist, Sr. performs a variety of tasks. Works under general supervision; typically reports to a manager. A certain degree of creativity and latitude is required. (Copyright 2024 Salary.com)

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Sr Product Development Sr Scientist I
  • System One
  • Brunswick, NJ OTHER
  • Title: Sr. Product Development Sr. Scientist I
    Location: Monmouth Junction, NJ
    Job Type: Direct Hire
    Hours: M-F 8AM-5PM

    Overview:
    The Product Development (PD) Senior Scientist I, under minimal guidance, designs, plans and conducts pre-formulation, formulation and process development activities as well as scale-up trials of complex projects using risk-based approach. The incumbent plans, coordinates and executes current Good Manufacturing Practices (cGMPs) pilot and pivotal/submission batches, including all required documentation. They prepare technical and product development reports and regulatory submission document and performs critical analysis.

    Responsibilities:

    • Carries out responsibilities in accordance with the organization’s policies, Standard Operating Procedures (SOPs), and state, federal and local laws
    • Creates invention disclosures; Collaborates with internal and external counsel to perform patent landscape analysis, draft patent applications, and respond to office actions
    • Utilizes risk-based approaches and Quality by Design (QbD) principles in guiding pharmaceutical development and identifying critical quality attributes (CQA), critical material attributes (CMA), critical process parameters (CPP) and control strategies. Uses problem solving tools to trouble shoot, as needed
    • Designs and conducts physical and chemical characterization in liaison with analytical teams
    • Performs critical data analysis using statistical tools including stability analysis
    • Liaises, coordinates and manages PD activities with external labs, Clinical Research Organizations (CROs) and Clinical Development Manufacturing Organizations (CDMOs), including cGMP manufacturing activities; Collaborates closely with other functions within and outside R&D to ensure project timelines are met
    • Authors regulatory submission documents for New Drug Application (NDA)/Abbreviated New Drug Application (ANDA), supplements, annual reports and Investigator Responses (IR)/Complete Response Letters (CRLs), covering pharmaceutical development and manufacture, including product development reports
    • Collaborates with Quality Assurance (QA) department on investigations, Corrective Action Preventive Action (CAPAs) and changes controls, as needed; Supports Technical Services and Operations departments to troubleshoot scale up and commercial processes
    • Participates in training of new employees and mentors lower level scientists
    Requirements:
    • BS  Degree in Pharmaceutical Science or related scientific field WITH Minimum 10 years experience in pharmaceutical formulation and product development 
    OR 
    • MS  Degree in Pharmaceutical Science or related scientific field WITH Minimum 8 years experience in pharmaceutical formulation and product development. 
    OR 
    • PhD Degree in Pharmaceutical Science or related scientific field WITH minimum 3 years experience in pharmaceutical formulation and product development
    • In depth experience designing and conducting oral controlled release solids and liquids pharmaceutical formulation and process development studies with high scientific standard of multiple dosage forms
    • Working knowledge of QbD and risk-based approaches
    • Working knowledge of Food and Drug Administration (FDA), cGMPs, Drug Enforcement Administration (DEA), Occupational, Safety and Health Administration (OSHA), SOPs and regulatory rules, regulations and guidelines
    • Strong technical writing skills and experience (i.e., SOPs, investigations, protocols, reports, submission documents, etc.)
    • Proficiency with Microsoft Office
    • Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
    • Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines 
    • Planning, organization and time management skills including the ability to support and prioritize multiple projects
    Benefits
    Our client provides a comprehensive benefits package.  Their benefits include competitive salaries, 401(k) plans with company match, medical, dental, and vision insurance, paid time off (vacation, sick leave, personal leave), paid parental leave, tuition reimbursement, life insurance, disability insurance, employee assistance program, on-site fitness center, free snacks and drinks, and casual dress code.
    • As this is a direct hire with our client System One benefits described below would not apply to this role.  Benefits program listed above would be those applicable to this role. 

     

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Sr Specialist, Channel Marketing
  • Ansell
  • Iselin, NJ FULL_TIME
  • Why Ansell? Ansell is a leading global provider of protection solutions designed, developed, and manufactured to meet the ever-changing needs and demands of our markets and industries. Protection is o...
  • 1 Month Ago

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Workforce Development Specialist
  • Medical Facilities of America Administrative...
  • Lakewood, NJ FULL_TIME
  • Medical Facilities of America, a regional leader in healthcare and skilled nursing services, is seeking a qualified individual to join our growing team as a Workforce Development Specialist in our Lak...
  • 20 Days Ago

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Training and Development Specialist
  • TDK-Lambda Americas
  • Neptune, NJ FULL_TIME
  • As an essential member of the TLA HR department, the Training and Development Specialist will be responsible for the training, certification, and development of employees at all levels in a wide varie...
  • 23 Days Ago

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Real Estate Development Specialist
  • Middlesex County
  • Brunswick, NJ OTHER
  • Overview POSITION OVERVIEW: The Real Estate Development Specialist will align the Office of Business Engagement strategies, with direction from the Division Head of Real Estate. The role will support ...
  • 2 Days Ago

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Business Development Specialist
  • Brenntag
  • Iselin, NJ FULL_TIME
  • BUSINESS DEVELOPMENT SPECIALIST Our team in South Plainfield currently has an opening for a Business Development Specialist YOUR ROLE & RESPONSIBILITIES Job Summary: The Business Development Specialis...
  • 10 Days Ago

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0 Organizational Development Specialist, Sr. jobs found in New Brunswick, NJ area

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Director, Dermatology Medical Engagement Lead (MD required) - REMOTE
  • Bristol-Myers Squibb Company
  • New Brunswick, NJ
  • Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But w...
  • 3/28/2024 12:00:00 AM

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Senior Therapeutic Area Specialist, Immunology (TAS) -Detroit MI
  • Bristol-Myers Squibb Company
  • New Brunswick, NJ
  • Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But w...
  • 3/28/2024 12:00:00 AM

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Senior Therapeutic Area Specialist, Immunology (TAS) - Toledo/Cleveland W, OH
  • Bristol-Myers Squibb Company
  • New Brunswick, NJ
  • Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But w...
  • 3/28/2024 12:00:00 AM

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Director, Hematology Medical Engagement Lead (MD required) - REMOTE
  • Bristol-Myers Squibb Company
  • New Brunswick, NJ
  • Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But w...
  • 3/26/2024 12:00:00 AM

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Outpatient Therapist
  • Youth Advocate Programs
  • New Brunswick, NJ
  • Status: Part-Time HourlyFLSA classification: Non- Exempt Summary of the Position: The Outpatient Therapist/Community Spe...
  • 3/25/2024 12:00:00 AM

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Clinical Nurse Consultant, Los Angeles, CA
  • Bristol-Myers Squibb Company
  • New Brunswick, NJ
  • Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But w...
  • 3/25/2024 12:00:00 AM

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Director, Oncology Medical Engagement Lead (MD required) - REMOTE
  • Bristol-Myers Squibb Company
  • New Brunswick, NJ
  • Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But w...
  • 3/25/2024 12:00:00 AM

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Director, Cardiovascular Medical Engagement Lead (MD required) - REMOTE
  • Bristol-Myers Squibb Company
  • New Brunswick, NJ
  • Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But w...
  • 3/25/2024 12:00:00 AM

According to the United States Census Bureau, the city had a total area of 5.789 square miles (14.995 km2), including 5.227 square miles (13.539 km2) of land and 0.562 square miles (1.456 km2) of water (9.71%). New Brunswick is in Raritan Valley (a line of cities in central New Jersey). New Brunswick is on the south side of Raritan Valley along with Piscataway Township, Highland Park, Edison Township, and Franklin Township (Somerset County). New Brunswick lies southwest of Newark and New York City and northeast of Trenton and Philadelphia. New Brunswick is bordered by Piscataway, Highland Park...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Organizational Development Specialist, Sr. jobs
$100,129 to $124,633
New Brunswick, New Jersey area prices
were up 1.5% from a year ago

Organizational Development Specialist, Sr. in Alexandria, VA
Meet or exceed continuing professional education (CPE) requirements.
April 16, 2020
Assist with business development activities, such as proposals, capture, account teams, whitepapers, conferences, and/or other thought leadership materials.
April 18, 2020
Meet or exceed targeted billing hours (utilization).
June 04, 2020