Overview
On Site
$47 - $48 hr
Contract - Independent
Contract - W2
Contract - 24+ mo(s)
Skills
TECH TRANSFER
TECHNOLOGY TRANSFER
MANUFACTURING
GMP
SMARTSHEET
SMART SHEET
PROJECT
MS PROJECT
NEW PRODUCT INTRODUCTION
NPI
PRODUCT
COMBINATION PRODUCT
COMBINATION PRODUCTS
MEDICAL DEVICE
MEDICAL DEVICES
SURGICAL
INJECTIONS
INFUSER
DRUG DELIVERY
DELIVERY DEVICE
DELIVERY DEVICES
INJECTOR
PHARMA
PHARMACEUTICAL
BIOTECH
BIOTECHNOLOGY
THERAPEUTIC
BIOPHARMA
BIOPHARMACEUTICAL
Job Details
Payrate: $47.00 - $48.00/hr.
Responsibilities:
Basic Qualifications:
Preferred Experience:
Skills:
Top 3 Must Have Skill:
Pay Transparency: The typical base pay for this role across the U.S. is: $47.00 - $48.00 /hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying STOP to messages or by contacting
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our .
#AditiConsulting
#25-23158
Responsibilities:
- In this dynamic role, you will organize Technology Transfer activities for Final Drug Product (FDP) manufacturing.
- Responsibilities include supporting and creating project schedules, lead site assessment and manufacturing capabilities, updating project dashboards, and leading team meetings to progress the project towards final objectives. You will work across a global, cross-functional team consisting of manufacturing, device and packaging design for combination products, capital projects, physical test methods, quality, and regulatory team members.
- Your role will focus on leading effective Tech Transfer projects for combination products, enhancing end-to-end controls with robust methods and data flow in a GMP setting.
- Supporting New Product Introduction to manufacturing site.
- Owning documentation such as Project Plan, supporting engineering with Process Transfer Documents (PTD), protocols, and reports.
- Supporting engineers with Make-a-Batch (M-a-B) activities to ensure sending/receiving site expectations are met.
- Developing, tracking, and providing project dashboard updates.
- Providing good communication plans to cross-functional teams and Process Engineer management.
- Ability to apply project management and engineering science to production.
- Strong teamwork and excellent interpersonal and communication skills.
Basic Qualifications:
- Master s degree or bachelor s degree and 2 years of experience OR associate s degree and 6 years of experience OR High school diploma/GED and 8 years of experience
Preferred Experience:
- Experience in the Tech Transfer of Combination Product field, focusing on project management and/or manufacturing.
- Understanding of interdependencies of complex projects, especially involving new product introductions with new equipment/processes.
- Knowledge of Combination Product design controls and regulatory requirements on a global scale.
- Familiarity with commercialization framework.
- Program and Project Management skills (experience with MS Project, SmartSheets, and other project scheduling software is desired).
Skills:
- Strong English written and verbal communication skills
- MS Office
- Smartsheet (project scheduling software)
- project management experience in a supporting role.
- Proactive risk assessment, management, and mitigation.
- Ability to lead and succeed in an ambiguous environment.
- Strong project management skills.
Top 3 Must Have Skill:
- Tech Transfer
- Engineer
- Project Management
Pay Transparency: The typical base pay for this role across the U.S. is: $47.00 - $48.00 /hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying STOP to messages or by contacting
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our .
#AditiConsulting
#25-23158
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.