JOB SUMMARY

Responsible for driving all aspects of the Analytical and Microbiological Quality Control (QC) laboratories at Genezen. This individual provides leadership, scientific and technical expertise for all QC activities, as well as support to Analytical Development for all method qualification/validation activities. This person is also the facility aseptic subject matter expert, including responsibilities for the environmental monitoring program. The ideal candidate must have in-depth knowledge and experience in a cGMP/ GLP testing lab.

ESSENTIAL JOB FUNCTIONS

• Ensure timely in-process and release testing of early clinical grade biopharmaceuticals
• Maintain familiarity with current analytical and bioassay methods used for characterizing viral vectors (Assays include genome titer by Flow, ELISA, qPCR, ddPCR, genome integrity assay, empty/full particle ratio assay, and cell-based assays)
• Monitor, maintain and continuously improve the environmental monitoring program, including conducting Environmental Monitoring Performance Qualifications as needed
• Develop, implement and maintain EM trending program and metrics, including Annual Reports and evaluation of alert levels
• Develop, implement and maintain an in-house isolates program
• Responsible for Disinfectant Efficacy Program
• Responsible for the Analytical laboratory equipment systems and software (e.g., ddPCR, Flow, etc.) including purchase, calibration, IOPQ activities, etc. to meet the compliance (data integrity) requirements and project timelines.
• Support the Analytical Development team in qualification/validation of analytical methods to support the cGMP manufacturing of viral vectors
• Support the tech transfer of bioassays from clients to cGMP QC testing lab
• Represent QC Analytical and Microbiological in client meetings and programs
• Establish and maintain the stability program
• Oversee LIMS development, implementation, operation, troubleshooting and maintenance
• Responsible for all laboratory logistics activities including, but not limited to sample management, test/release schedule, cycle time matrix, capacity management, etc.
• Manage outside contract laboratory relationships, including method qualification/validations, investigations, audits, cost and invoices to meet project timelines and business requirements
• Support OOSs/OOTs and other lab investigations, deviations, CAPAs, change controls, audits, and training
• Analyze regulatory authorities’ programs, guidance documents, and activities in areas relevant to testing of cell and gene products
• Develop, implement and present metrics for monitoring of lab operations and stability program
• Participation in client audits and regulatory inspections as SME and development of responses to observations
• Responsible for hiring and development of team members, conduct performance review and disciplinary actions.
• Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the QC functional area

 KNOWLEDGE, SKILLS, AND EXPERIENCE

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• Occasionally exposed to extremely loud noise levels
• Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required

Movement

•  Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Occasionally lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail

Real Chemistry is a global health innovation company with offices across the US and Europe. We believe that the way to real, transformative change is through the uncommon combination of disciplines, technologies, and our greatest asset – our people. We are currently looking to add to our alchemic mix of more than 1,800 talented professionals. This is a great opportunity to join a dynamic, fast-growing global company committed to making the world a healthier place for all.

This is a hybrid role, based in New York City, Boston, Chicago, Carmel, or San Francisco—or remotely within the US, depending on team and business needs. 

Job Summary:

The Senior Art Director is a senior-level creative contributor within the agency who may interface directly with Real Chemistry clients as well as all areas of the organization. Primary responsibilities include guiding the ideation and creative development for projects, business development, and some corporate marketing as needed. In addition to possessing an excellent knowledge of effective graphic and/or presentation design techniques (via both the Adobe Creative Suite and Microsoft Office, especially Word and PowerPoint), a successful Senior Art Director should possess a thorough understanding of the principles of successfully integrating copy with art and layouts. This position also requires strong creative problem-solving skills and the ability to translate strategic ideas into polished deliverables and then present them to key stakeholders.   

What you'll do:

Otherwise known as the “essential functions”, these are the parts of the job that a crucial to successful performance. 

• Provide quality assurance for all related design deliverables 
• Manage/lead/direct promotional art projects  
• Assess client needs, propose, and develop innovative multimedia solutions 
• Understand and develop new technology to maintain agency competitiveness 
• Possess advanced experience with Adobe Creative Suite, particularly InDesign, Illustrator, and Photoshop 
• Provide a work breakdown structure (WBS) and budget for complex deliverables 
• Communicate effectively, both orally and in writing 
• Potential to supervise and train employees, to include organizing, prioritizing, and scheduling work assignments 
• Fulfill other duties and responsibilities deemed necessary by supervisor 
• Any other duties as reasonably assigned; duties and responsibilities may be removed, modified, or added by leadership at any time as business or operations require

This position is a perfect fit for you if:

• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving.
• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data.
• You are highly organized self-starter, able to work independently and under tight deadlines. 

What you should have: 

• Bachelor's degree in arts, graphic arts, related field, or similar work experience is required 
• Master’s degree in a related field (Digital Media, Electronic Visualization, Visual Arts, Computer Graphic Design) is preferred 
• At least 6 years of professional art/design/creative writing experience demonstrated by a strong design portfolio 

Pay Range: $85,000-$95,000

This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time. 

21GRAMS, a Real Chemistry subsidiary is an advertising agency born to make healthcare more human. Not just in our work, but in the way we conduct business, approach client relationships, and treat each other. It’s a place where people subscribe to the adage, “Be good to each other, but hard on the work.” A place where people are not just in it for the paycheck, but to make a dent in the universe. Sound like you? 

This is a hybrid role, based in any of our US offices—including New York City, Boston, Chicago, Carmel, or San Francisco—or remotely within the US, depending on team and business needs.

Role summary:  

21GRAMS is in search of a Senior Art Director to generate and delivery quality creative materials. Art directors are responsible for the visual style, art, images and photographs and must adhere to client’s marketing strategies, objectives, and expectations. The main objective is to promote business growth by developing groundbreaking creative concepts

What you'll do:

• Develop and execute creative marketing strategies that encompasses and meets the client’s marketing strategies and objectives

• Understand and maintain understanding of client’s positions and the current marketing environment to adapt and navigate to success

• Oversee a team to ensure quality for a final product

• Communicate with team members in a productive manner to ensure goals are being met

• Think strategically with understanding of assigned accounts, medical categories, and market

This position is a perfect fit for you if:  

• ​Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you.  

• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving.  

• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data.  

• You are highly organized self-starter, able to work independently and under tight deadlines.  

What you should have:   

• Bachelor’s Degree

• 3+ years of healthcare advertising experience preferred

• Experience in healthcare advertising

• Effective oral and written communication skills

• Computer proficiency with knowledge of design programs

• Managerial and leadership skills and the ability to work with a team

• Decisive problem-solving abilities

Pay Range: $100,000.00-$115,000.00

This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time. 

Real Chemistry is looking for a Group Copy Supervisor to join our growing team!  

21GRAMS, part of Real Chemistry, takes an innovative approach to advertising, and focusing on making healthcare more human.  Not just in our work, but in the way we conduct business, approach client relationships, and treat each other. It’s a place where people subscribe to the adage, “Be good to each other, but hard on the work.” A place where people are not just in it for the paycheck, but to make a dent in the universe. Sound like you? 

The Group Copy Supervisor is a brand steward and category champion, responsible for having a deep understanding of the brand, its benefits, and competitive differentiation. Working with art partners and reporting to a Creative Director, the Group Copy Supervisor will own all day-to-day writing responsibilities for assigned healthcare/pharma-related HCP accounts. The ideal candidate will have the skills and experience to think strategically, supply creative ideas and concepts, and execute across a range of mediums.

This is a hybrid role, based in any of our US offices—including New York City, Boston, Chicago, Carmel, or San Francisco—or remotely within the US, depending on team and business needs.

What you’ll do: 

• Responsible for writing headlines and body copy for various types of digital tactics, including websites, interactive visual aids, videos, banners, landing pages, and emails, for branded and unbranded HCP clients

• Convey scientific information into compelling and memorable messages for HCP campaigns

• Champion creative thinking for campaigns and initiatives that advance creative strategy and brand personality

• Prepare materials for client copy approval submissions, ensuring pieces are referenced and annotated according to AMA style, without supervision

• Collaborate with Art Directors, Designers, and Developers from job initiation to digital deployment, and partner with Account and Strategy teams at all points

• Ability to independently lead multiple projects, sometimes for different brands/industries

• Clearly and expertly present work to clients and internal team members

This position is a perfect fit for you if: 

• ​Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you. 

• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving. 

• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data. 

• You are highly organized self-starter, able to work independently and under tight deadlines. 

What you should have:  

• 7+ years healthcare/pharmaceutical writing, preferably in an agency setting

• College degree in a related field preferred

• Experience writing for the healthcare/pharmaceutical industry

• Portfolio or PDF of relevant work samples required

Pay Range: $120,000 - $135,000
This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time.

Real Chemistry is looking for an Associate Creative Director, Art to join our growing team!  

21GRAMS, a Real Chemistry subsidiary is an advertising agency born to make healthcare more human. Not just in our work, but in the way we conduct business, approach client relationships, and treat each other. It’s a place where people subscribe to the adage, “Be good to each other, but hard on the work.” A place where people are not just in it for the paycheck, but to make a dent in the universe. Sound like you? 

21GRAMS is looking for an Associate Creative Director, Art. A brand steward and category champion, responsible for having a deep understanding of the brand, its benefits, and driven distinction. With a drive for creativity and purpose. With a hands on approach to leadership and team building. 

This is a hybrid role, based in any of our US offices—including New York City, Boston, Chicago, Carmel, or San Francisco—or remotely within the US, depending on team and business needs.

What you’ll do: 

• Responsible for art direction and design across a variety of tactics 

• Convey scientific information into compelling and memorable messages campaigns 

• Champion creative thinking for campaigns and initiatives that advance creative strategy and brand personality 

• Deployment, and partner with Account and Strategy teams at all points 

• Ability to independently lead multiple projects, sometimes for different brands/industries 

• Clearly and confidently present work to clients and internal team members 

• Review and complete employee performance feedback  

• Build a working relationship between the business and clients  

• Work closely with art/design, tech, editorial, and project management departments to ensure that deadlines and budgets are met  

• Assign creative teams best suited for each project based on ability and workload 

• Identify and interview prospective creative candidates  

This position is a perfect fit for you if: 

• Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you. 

• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving. 

• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data. 

• You are highly organized self-starter, able to work independently and under tight deadlines. 

What you should have:  

• 10+ years healthcare/pharmaceutical art direction and design 

• Experience in the healthcare/pharmaceutical industry in an agency setting required 

• Portfolio or PDF of relevant work samples required 

• Must have Oncology experience

Pay Range: $165,000 – $180,000
This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time.

Real Chemistry is looking for a Copy Supervisor to join our growing team!  

21GRAMS, part of Real Chemistry, takes an innovative approach to advertising, and focusing on making healthcare more human.  Not just in our work, but in the way we conduct business, approach client relationships, and treat each other. It’s a place where people subscribe to the adage, “Be good to each other, but hard on the work.” A place where people are not just in it for the paycheck, but to make a dent in the universe. Sound like you? 

The Group Copy Supervisor is a brand steward and category champion, responsible for having a deep understanding of the brand, its benefits, and competitive differentiation. Working with art partners and reporting to a Creative Director, the Group Copy Supervisor will own all day-to-day writing responsibilities for assigned healthcare/pharma-related HCP accounts. The ideal candidate will have the skills and experience to think strategically, supply creative ideas and concepts, and execute across a range of mediums.

This is a hybrid role, based in any of our US offices—including New York City, Boston, Chicago, Carmel, or San Francisco—or remotely within the US, depending on team and business needs.

What you’ll do: 

• Responsible for writing headlines and body copy for various types of digital tactics, including websites, interactive visual aids, videos, banners, landing pages, and emails, for branded and unbranded HCP clients

• Convey scientific information into compelling and memorable messages for HCP campaigns

• Champion creative thinking for campaigns and initiatives that advance creative strategy and brand personality

• Prepare materials for client copy approval submissions, ensuring pieces are referenced and annotated according to AMA style, without supervision

• Collaborate with Art Directors, Designers, and Developers from job initiation to digital deployment, and partner with Account and Strategy teams at all points

• Ability to independently lead multiple projects, sometimes for different brands/industries

• Clearly and expertly present work to clients and internal team members

This position is a perfect fit for you if: 

• ​Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you. 

• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving. 

• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data. 

• You are highly organized self-starter, able to work independently and under tight deadlines. 

What you should have:  

• 7+ years healthcare/pharmaceutical writing, preferably in an agency setting

• College degree in a related field preferred

• Experience writing for the healthcare/pharmaceutical industry

• Portfolio or PDF of relevant work samples required

Pay Range: $120,000 - $135,000
This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time.