Top 92 Lead Authoring Engineer Jobs

Advisor - Technical Lead Scientist - Advanced Therapies Manufacturing
Lilly —Lebanon, IN
- $129,000 - $189,200 a year
- Full-time
- Bachelor of Science
- 3 years
- Bachelor's degree
- Health insurance
- Dental insurance
Lead Manufacturing Process Engineer
Phoenix Engineering —Detroit, MI
- $52.53 - $63.46 an hour
- Full-time
- 5 years
- Databases
- Bachelor's degree
Quick Apply
AMRAAM Software Integrated Product Team Lead (IPTL)
Raytheon —Tucson, AZ
- $107,500 - $204,500 a year
- Full-time
- 8 years
- C++
- Supervising experience
- Paid holidays
- Disability insurance
Sr. Systems Engineer, Qualification Test Lead
Raytheon —Tucson, AZ
- $86,800 - $165,200 a year
- Full-time
- Management
- Software troubleshooting
- Laboratory experience
- Paid holidays
- Disability insurance
Continuous Improvement Leader – Engineer III
Materion Brush Inc —Elmore, OH
- $92,200 - $125,790 a year
- Full-time
- 5 years
- Engineering
- Product management
- Paid holidays
- Health insurance
Quick Apply
Tomahawk Production & Recertification Engineering Deputy Lead
Raytheon —Tucson, AZ
- $132,400 - $251,600 a year
- Full-time
- Supervising experience
- Presentation skills
- Senior level
- Paid holidays
- Disability insurance
Lead Data Engineer
Walker & Dunlop —Remote
- $170,000 - $190,000 a year
- Full-time
- Remote
- Computer science
- Computer Science
- 8 years
- Wellness program
- Commuter assistance
Cleared Senior/Principal R&D Mechanical Engineer - Explosive Components Product Realization Team Lead, Onsite
Sandia National Laboratories —Albuquerque, NM
- $117,500 - $235,700 a year
- Full-time
- Oracle
- Pass drug screening
- Bachelor's degree
- Relocation assistance
- Health insurance
Lead DevOps Engineer
Charles Schwab —Austin, TX
- $150,000 - $175,000 a year
- Hybrid work
- Computer science
- Computer Science
- Software troubleshooting
- Paid parental leave
- Employee stock purchase plan
Lead Cybersecurity Engineer
Visa Technology and Operations LLC —Bellevue, WA
- $180,000 - $288,000 a year
- Full-time
- Hybrid work
- Azure
- 11+ years
- Office
- Wellness program
- Health savings account
Lead Electrical Engineer - Input Engineering
Apple —Cupertino, CA
- $150,400 - $277,600 a year
- Doctor of Philosophy
- Senior level
- Electrical Engineering
- Employee stock purchase plan
- Health insurance
5d
Sr Lead CQV and CSV Engineer
VTI Life Sciences —Thousand Oaks, CA
- Temporary
- 8 years
- Senior level
Quick Apply
Senior CQV Engineer / Validation Lead
Validation & Engineering Group, Inc —Chaska, MN
- Remote
- Engineering
- In-person
- Senior level
Quick Apply
Lead Cloud DevOps Engineer (Oakland Office)
Fictiv —Oakland, CA
- $180,000 - $220,000 a year
- 5 years
- System design
- Office
- Health insurance
- Dental insurance
Integration & Test Engineer (Experienced, Lead or Senior
Boeing —Tukwila, WA
- $119,850 - $239,200 a year
- Urgently hiring
- Computer Science
- Bachelor of Science
- Engineering
- Health savings account
- Disability insurance
7d
OBD Requirements Engineer – Generic Scan Tool Lead
Scout Motors —Novi, MI
- $160,000 - $192,500 a year
- Full-time
- 18 years or older
- Computer Science
- Engineering
- Paid jury duty
- Paid parental leave
Quick Apply
6424 - Lead Validation Engineer (Data Lake) / CSV Engineer
Verista, Inc. —Conshohocken, PA
- $87,780 - $136,225 a year
- Computer Science
- Bachelor's degree
- Senior level
- Commuter assistance
- Paid parental leave
Quick Apply
Advanced Manufacturing & Mission Realization Lead (R&D Engineer 3/4)
Los Alamos National Laboratory —Los Alamos, NM
- $128,000 - $266,500 a year
- Email
- 18 years or older
- 6 years
- Engineering
- Disability insurance
- Health insurance
Lead Process Development Engineer
Interactive Resources Ir —Huntersville, NC
- $150,000 a year
- Analysis skills
- In-person
- Senior level
Lead, Manufacturing Engineer, Mechanical Assembly (Fluid Systems)
Relativity Space —Long Beach, CA
- $132,000 - $198,000 a year
- 5 years
- Bachelor of Science
- Analysis skills
- Opportunities for advancement
Quick Apply

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Advisor - Technical Lead Scientist - Advanced Therapies Manufacturing

Lilly -
Lebanon, IN

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Job Details

Full-time
$129,000 - $189,200 a year

Benefits

Health insurance
Dental insurance
401(k)
Flexible spending account
Employee assistance program
Vision insurance
Life insurance

Qualifications

Biotechnology
Biotechnology
Manufacturing facility experience
Bachelor's degree
Pharmaceutical company experience
Regulatory submission editing and review
Communication with regulatory authorities for clinical trials
Pharmaceutical manufacturing facility experience

Full Job Description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Lilly is currently constructing a cutting edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team to help build a state-of-the-art facility and Technical System from the ground up, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply. The TS/MS team will own all areas of technology transfer, process validation, and process stewardship.

Position Description:

Technical Lead – Technical Services/Manufacturing Scientist (TS/MS) role will provide technical leadership and oversight to clinical and commercialization activities of gene therapy product at the Lebanon Advanced Therapies (LP2) site. The scope of the role includes all clinical trial and commercialization gene therapy products such as technology transfer, validation, drug substances and products production, inspection, submission and filing.

The TS/MS Technical Lead can be involved with clinical trials and supports all commercialization activities up to submission and approval of the DP by providing technical support to ensure processes are in alignment with Lilly Manufacturing Standards of Operational Excellence (MSOE), Lilly Global Quality Standards (GQS), Lilly Quality Standards (LQS), and LP2 commercialization procedures.

The TS/MS Technical Lead works with functional teams such as Engineering, Operations, Quality and Regulatory as well as other local/global teams throughout the commercialization process.

Key Objectives/Deliverables

Understand the scientific principles required for manufacturing intermediates, bulk drug substances and drug products for gene therapy products commercialization.
Provide product and process technical knowledge to identify appropriate manufacturing approaches for processing of new products.
Support identification and development of new manufacturing technologies and processes to support commercialization.
Lead risk management activities as it pertains to new products (FMEA).
Own Tech Transfer strategy for the manufacturing site.
Ensure that an accurate instruction set (eBRs and procedures) and PFD describe the process and control strategy for new products.
Drive technical excellence through meaningful specifications, including approval of local specifications and influencing global specifications.
Understand, justify, and document the process validation strategy for new products.
Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: tech transfer risk assessments / plans / reports, change controls, regulatory submissions, deviation investigations, stability strategies, validations, procedures, specifications, PFDs, etc.
Manufacturing site representative for new product regulatory submissions, including authoring and/or reviewing relevant submission document sections.
Collaborate with Commercialization Project Manager as well as cross-functional tech transfer team members to commercialize new products in LP2.
Serve as technical interface with development.
Communicate effectively with process team members, development colleagues, tech transfer team members, and other parties.
Identify opportunities for best practices and implement improvements to manufacturing technology.
Own and prepare Annual Product Reviews, etc.

Basic Requirements:

B.S. in Biotechnology, Biochemistry or related quantitative field
3+ years of experience in pharmaceutical/biotech manufacturing industry
1+ year of experience with new product submission and filing

Additional Preferences:

Experience with product commercialization
Demonstrated experience managing and collaborating with CMOs
Demonstrated technical capability with high productivity
Proven track record of curiosity with learning agility
Self-starter with high initiative and data-driven approach to problem-solving
Demonstrated strong interpersonal skills
Demonstrated strong verbal and written communication skills
Demonstrated adaptability and flexibility to working in different environments, teams etc.
Demonstrated ability to participate in and facilitate decision-making

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$129,000 - $189,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly

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Refine Your Search

Lead Authoring Engineer jobs

Advisor - Technical Lead Scientist - Advanced Therapies Manufacturing

Lead Manufacturing Process Engineer

AMRAAM Software Integrated Product Team Lead (IPTL)

Sr. Systems Engineer, Qualification Test Lead

Continuous Improvement Leader – Engineer III

Tomahawk Production & Recertification Engineering Deputy Lead

Lead Data Engineer

Cleared Senior/Principal R&D Mechanical Engineer - Explosive Components Product Realization Team Lead, Onsite

Lead DevOps Engineer

Lead Cybersecurity Engineer

Lead Electrical Engineer - Input Engineering

Sr Lead CQV and CSV Engineer

Senior CQV Engineer / Validation Lead

Lead Cloud DevOps Engineer (Oakland Office)

Integration & Test Engineer (Experienced, Lead or Senior

OBD Requirements Engineer – Generic Scan Tool Lead

6424 - Lead Validation Engineer (Data Lake) / CSV Engineer

Advanced Manufacturing & Mission Realization Lead (R&D Engineer 3/4)

Lead Process Development Engineer

Lead, Manufacturing Engineer, Mechanical Assembly (Fluid Systems)

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