Senior Director NPI Operations

Molecular Assemblies is a San Diego-based company developing a revolutionary, enzymatic DNA synthesis technology capable of powering new products in industrial synthetic biology, personalized therapeutics, precision diagnostics, and eventually information storage, nanotechnology and more.

We are seeking a seasoned Director / Sr. Director of NPI Operations who will lead and execute the transfer of R&D oligo synthesis workflows and establish pilot scale high throughput manufacturing systems for our synthetic oligonucleotide and gene products. The candidate will work as a member of an experienced R&D, Finance and Sales & Marketing management team to implement the necessary infrastructure to meet our revenue plans.  The Director / Sr. Director of NPI Operations will lead a growing team in the planning, implementation, execution, and day-to-day operation of the manufacturing, QC, packaging, and shipping of our nucleic acid products.

Duties:

  • Establish and oversee end-to-end manufacturing operations processes ensuring performance to quality, turn around time, volume, and financial goals.
  • Build a manufacturing organization for the HT synthesis of DNA oligonucleotides and genes based on Molecular Assemblies proprietary technology.
  • Coordinate with the various R&D teams in transferring oligo and gene synthesis production workflows, automation technologies, and reagent formulation procedures on-line from pilot scale operational capability to high throughput volumes according to project timelines.
  • Establish a culture of continuous improvement resulting in ongoing improvements in product quality, turn around time, and COGS.
  • Create and implement departmental SOP’s that execute the required processing tasks and meet the relevant quality system requirements.
  • Create annual and multi-year departmental headcount, expense, and capital budgets.
  • Identify, plan, and implement year-over-year growth in product manufacturing capability and year-over-year decrease in COGS.
  • Proactively identify risks to departmental success and propose action plans for resolution.

Required Experience & Skills

  • Proven track record of high volume, customized biotechnology product manufacturing; experience in synthetic oligonucleotide and/or gene synthesis highly desired
  • Experience in process transfer and scale-up from development to manufacturing environments.
  • Experience multi-stage end-to-end process driven products.
  • Experience in a highly automated processing environment and information systems desired.
  • Experience in developing high performing team and a culture of continuous improvement.
  • Excellent analytical, organizational, communications, presentation, and written skills

Qualifications:

  • BS or greater in mechanical engineering, bio-engineering, physics, chemistry, molecular biology or another related field
  • 5+ years in direct manufacturing experience

Scientist I – QC Development

Molecular Assemblies is a San Diego-based company pioneering an enzymatic DNA synthesis technology towards more accurate and longer synthesis product compared to traditional chemical synthesis. This technology is capable of powering new products in industrial synthetic biology, personalized therapeutics, precision diagnostics, and eventually information storage, nanotechnology and more.

This candidate will be a crucial contributor to the team by defining our QC workflows as part of the biochemistry development team, helping define and ensure our reagent formulation processes meet requirements and specifications.

RESPONSIBILITIES:

  • Define Quality Control (QC) workflows with the goal of ensuring raw and in-process materials to meet requirements for enzymatic DNA synthesis.
  • Perform tasks related to QC functional responsibilities such as, quality requirements, stability, validations, inventory maintenance, and continuous improvement efforts.
  • Perform test and inspection procedures in compliance with written and approved standard operating procedures (SOP).
  • Create (SOP) related to analytical and functional methods or other laboratory operations such as sample management, stability programs, product release or storage controls.
  • Create Certificates of Testing, Certificates of Analysis and other applicable lot release documentation as needed.
  • Create and own medium to high-risk Non-Conformances/Deviations/CAPAs.
  • Lead and participate in cross-functional teams.
  • Documentation of experimental results in ELN; preparation and presentation of experimental results, reports and project plans to R&D colleagues and company management.

REQUIRED EXPERIENCE & SKILLS:

  • Minimum of 3 years hands-on experience in a manufacturing or R&D laboratory or equivalent.
  • Strong analytical chemistry and biochemistry skill set.
  • Direct experience in QC and reagent development is a plus.
  • Basic knowledge of enzyme activity and kinetics is required.
  • Experience with independent experimental design and execution, data analysis, and troubleshooting.
  • Experience with liquid handling robots a plus.
  • Strong work ethic and team player.
  • High attention to detail, highly organized and strong documentation skills.

EDUCATIONAL LEVEL, EDUCATIONAL DISCIPLINES:

  • Minimum B.S. (with 7+ years), M.S. (with 5+ years) or Ph.D. (with 1+ years) research/industry experience in lab environments, respectively, with degrees in Life Sciences (Molecular Biology, Biology, Chemistry, Biochemistry, Biotechnology) disciplines.

Scientist II to IV – Molecular Biology

Molecular Assemblies is a San Diego-based company developing a revolutionary, enzymatic DNA synthesis technology capable of powering new products in industrial synthetic biology, personalized therapeutics, precision diagnostics, and eventually information storage, nanotechnology and more.

As a Scientist II to Scientist IV, you will work closely with the biochemistry and instrumentation teams to advance Molecular Assemblies’ proprietary automated enzymatic synthesis workflow. This collaborative position will advance enzymatic synthesis by optimization of existing oligonucleotide synthesis workflows to tie into downstream applications in synthetic biology.

RESPONSIBILITIES:

  • Independently plan and execute experiments to develop and advance enzymatic oligo synthesis technologies towards company goals in synthetic biology.
  • Lead and mentor a small team towards accomplishing synthetic biology goals.
  • Collaborate cross-functionally with biochemistry and instrument teams to translate manual procedures into automated instrumentation and workflows.
  • Documentation of experimental results in ELN; preparation and presentation of experimental results, reports and project plans to R&D colleagues and company management.
  • Define sequence analysis workflows with the goal of establishing QC parameters.
  • Interface with suppliers or external collaborators.

REQUIRED EXPERIENCE & SKILLS:

  • Minimum of 2 years hands-on experience in an R&D laboratory or equivalent.
  • Strong molecular biology skill set, including PCR, DNA assembly, and sequencing.
  • Direct experience in synthetic biology (gene synthesis/DNA assembly/sequence design) a must.
  • Experience with independent experimental design and execution, data analysis, and troubleshooting.
  • Strong team leadership and collaborative skills.
  • Proficiency with NGS library preparation, sequencing, and data analysis is a plus.
  • Experience with liquid handling robots a plus.
  • Excellent organizational skills.
  • Strong work ethic, team player.
  • Strong written, oral, and presentation communication skills.

EDUCATIONAL LEVEL, EDUCATIONAL DISCIPLINES:

Minimum M.S. (with 7+ years) or Ph.D. (with 2+ years) research/industry experience in lab environments, respectively, with degrees in Life Sciences (Molecular Biology, Biology, Chemistry, Biochemistry, Biotechnology) disciplines.

Please direct inquiries to jobs@molecularassemblies.com

Research Associate / Scientist – Sequencing

Molecular Assemblies is a San Diego-based company developing a revolutionary, enzymatic DNA synthesis technology capable of powering new products in industrial synthetic biology, personalized therapeutics, precision diagnostics, and eventually information storage, nanotechnology and more.

We are considering a range of candidates from Research Associate III to Scientist II for this opportunity. In this role, you will advance Molecular Assemblies’ proprietary automated enzymatic synthesis workflow by developing improved sequence analysis capabilities. This collaborative position will work closely with the biochemistry and instrumentation teams.

RESPONSIBILITIES:

  • Independently plan and execute experiments to develop and establish improved sequence analysis capabilities, using cloning/sequencing and next generation sequencing (NGS) workflows.
  • Develop library preparation workflows and establish NGS analysis parameters for nucleic acids over a wide range of sizes.
  • Interface with bioinformatics team to define sequence analysis workflows with the goal of tracking sequence quality and establishing QC parameters.
  • Collaborate cross-functionally with biochemistry and instrument teams to translate manual procedures into automated instrumentation and workflows.
  • Document experimental results in ELN; preparation and presentation of results, reports, and project plans to colleagues and company management.
  • Interface with suppliers or external collaborators.

REQUIRED EXPERIENCE & SKILLS:

  • Minimum of 2 years hands-on experience in an R&D laboratory or equivalent.
  • Strong molecular biology skill set, including PCR, cloning/sequencing, NGS.
  • Direct experience with NGS library preparation and sequencing, with proficiency in data analysis a plus.
  • Experience with independent experimental design and execution, data analysis, and troubleshooting.
  • Experience with liquid handling robots a plus.
  • Excellent organizational and collaborative skills.
  • Strong work ethic, team player.
  • Strong written, oral, and presentation communication skills.

EDUCATIONAL LEVEL, EDUCATIONAL DISCIPLINES:

Minimum B.S. (with 5+ years), M.S. (with 2+ years) or Ph.D. (with 0+ years) of research/industry experience in lab environments, respectively, with degrees in Life Sciences (Molecular Biology, Biology, Chemistry, Biochemistry, Biotechnology) disciplines.

Please direct inquiries to jobs@molecularassemblies.com

Senior / Staff Engineer – Process Development

Molecular Assemblies is a San Diego-based company pioneering an enzymatic DNA synthesis technology towards more accurate and longer synthesis product compared to traditional chemical synthesis. This technology is capable of powering new products in industrial synthetic biology, personalized therapeutics, precision diagnostics, and eventually information storage, nanotechnology and more.

The Process Development Engineer will play a crucial role in solving complex multidisciplinary problems in consumable development to support the company’s proprietary biochemical process. This role will require a deep understanding in fluidics, surface chemistry, and process development as it pertains to instrument performance and manufacturing processes.

Responsibilities:

  • Drive the performance characterization and improvement of test platforms / breadboards for rapid evaluation of various consumables architectures
  • Spearhead mechanistic understanding of functionalized solid substrates and reagents
  • Perform root cause analysis and identify solutions
  • Collaborate cross-functionally with biochemistry and instrument groups to translate requirements and solve integration challenges
  • Establish critical parameters for workflows, accounting for operational reliability and robustness
  • Assist and guide teams in establishing best practices for development-scale consumables manufacturing, encompassing fluidic devices, functionalized solid substrates, and reagents.
  • Create and manage system architecture models encompassing runtime, volume, and other design parameters
  • Interface with suppliers or external collaborators.

Experience & Skills:

  • Expertise in process engineering methodologies such as FMEAs, SPC, Gauge RnR, DOE, root cause
  • Proven track record in surface characterization
  • Demonstrated understanding of integrated fluidic-based platforms for complex assays or biochemical processes
  • Self-driven, team player with ability to analyze and interpret multi-disciplinary experimental result to support design decisions
  • Experience with microfluidic devices for nucleic acid applications is a plus
  • Experience with manufacturing systems and workflows is a plus

Qualifications:

• MS or PhD in Bioengineering, Biochemistry, Physics, Mechanical Engineering or related field

• 3-5 years or greater of industry experience within product development or new product introduction organizations, with participation from platform feasibility to manufacturing transfer

Please direct inquiries to jobs@molecularassemblies.com

Research Associate II – Biochemistry

Molecular Assemblies is a San Diego-based company developing a revolutionary, enzymatic DNA synthesis technology capable of powering new products in industrial synthetic biology, personalized therapeutics, precision diagnostics, and eventually information storage, nanotechnology and more.

The R&D organization is seeking a highly motivated biochemist at the Research Associate level to support the development of enzymatic activity assays and perform testing. The position will report to the Director of Reagent Development and work closely with the Chemistry and Biochemistry Development teams to advance Molecular Assemblies’ proprietary oligonucleotide synthesis technology. Grade level is dependent on candidate experience.

RESPONSIBILITIES

  • Under the direction of senior staff, executes experiments in support of activity assay development.
  • Performs routine testing to support the goals of the R&D organization.
  • Maintains an electronic laboratory notebook using good documentation practices.
  • Helps author analytical SOPs and technical reports.
  • Proactively communicates observations and findings to senior staff.
  • Supports development of internal systems to improve organizational efficiencies.

REQUIRED EXPERIENCE & SKILLS

  • 1-year or more of hands-on laboratory experience is required.
  • Experience in an R&D laboratory is a plus.
  • Basic understanding of enzymology is required.
  • Highly motivated with a strong work ethic.
  • Excellent organizational skills.
  • Good collaborative skills and a team player.
  • Strong written, oral, and presentation communication skills.

QUALIFCATIONS

Minimum B.S. or B.A. in Biochemistry, Molecular Biology, Chemistry, or related field. Candidates with an M.S./M.A. or applicable R&D lab experience are encouraged to apply.

Please direct inquiries to jobs@molecularassemblies.com

Research Associate I, II – System Integration

Molecular Assemblies is a San Diego-based company developing a revolutionary, enzymatic DNA synthesis technology capable of powering new products in industrial synthetic biology, personalized therapeutics, precision diagnostics, and eventually information storage, nanotechnology and more.

The Research Associate I, II will work closely with the integration, biochemistry, and engineering teams to advance Molecular Assemblies’ proprietary automated enzymatic synthesis and DNA assembly workflows. This collaborative position will be responsible for supporting method development, reagent preparation, instrument setup, and sample processing, with a hands-on approach to troubleshooting.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Interface with Molecular Assemblies’ integration, biochemistry, chemistry, and instrumentation teams to perform automated enzymatic oligonucleotide synthesis and DNA assembly workflows.
  • Operate and maintain automated platforms, including supporting reagent preparation and sample processing efforts.
  • Perform detailed analysis of synthesis and/or DNA assembly performance.
  • Documentation of designs, test procedures, and test results in electronic laboratory notebook (ELN).
  • Presentation of results to R&D colleagues and company management.
  • General lab support, including supply and reagent inventory.
  • Interface with suppliers or external collaborators.

REQUIRED QUALIFICATIONS:

  • Minimum of 1 to 2 years hands-on experience in an R&D laboratory or equivalent.
  • Strong molecular biology/chemistry skill set.
  • Experience working with nucleic acids a plus.
  • Experience with experimental design and execution, data analysis, and troubleshooting.
  • Experience with automated microfluidic/liquid handling systems a plus.
  • Excellent organizational skills.
  • Strong collaborative skills.
  • Strong work ethic, team player.
  • Strong written, oral, and presentation communication skills.

PREFERRED EDUCATIONAL BACKGROUND:

Minimum B.S. or M.S. with 0-2+ years research/industry experience in lab environments, with degrees in Life Sciences (Molecular Biology, Biology, Chemistry, Biochemistry, Biotechnology) and/or Engineering (Biomedical Engineering, Chemical Engineering, Mechanical Engineering) disciplines.

Please direct inquiries to jobs@molecularassemblies.com

Senior Director Human Resources

Molecular Assemblies is a San Diego-based company developing a revolutionary, enzymatic DNA synthesis technology capable of powering new products in industrial synthetic biology, personalized therapeutics, precision diagnostics, and eventually information storage, nanotechnology and more.

Under the direction of the V.P, Finance and HR, the Senior Director, Human Resources manages the broad scope of HR operations including recruitment, employee relations, cultural development, compensation, benefits, performance management, policy development, risk management, training, and payroll.

RESPONSIBILITIES:

  • Review, modify, and implement company payroll policies, procedures, and guidelines to ensure compliance with government laws and regulations; provide appropriate training to management and employees regarding relevant federal and state employment laws; Oversee maintenance of personnel records in compliance with applicable laws.
  • Manage the new hire process from recruiting and interviewing to pre-hire testing and issuance of letters of employment
  • Administer benefit programs including life, health, disability insurance, PTO, leaves of absence, and employee assistance programs
  • Prepare annual workers comp, 401(k) census and support audit and other company or financial needs from payroll and personnel records; prepare compensation disclosures for various filings
  • Serve as an employee advocate to maintain practices that ensure a safe workplace, employee development, and open communication for problem resolution
  • Partner with management to identify and develop talent; ensure that each employee has an opportunity for career development and understands his/her growth opportunities; drive the feedback and performance review processes to ensure consistency, fairness and timeliness.
  • Provide support to management regarding all employee relations issues from coaching to corrective action; proactively maintain a positive work environment through a fair and consistent resolution process.
  • Participate in Health & Safety programs/initiatives; act as Company Safety Officer, if needed.
  • Provide other support to VP Finance and Human Resources, as needed 

MINIMUM QUALIFICATIONS:

  • Bachelor’s degree required. Advanced degree a plus; SPHR or SHRM-SCP certification desired.
  • Minimum 10 years work experience in human resources.
  • Previous HR and payroll experience.

REQUIRED KNOWLEDGE/SKILLS:

  • Strategic thinking ability.
  • Self-motivated; natural agility and flexibility in fast-changing and undefined situations.
  • Proactive approach toward management needs.
  • Excellent written and verbal communication skills.
  • Detail-oriented with strong organizational skills to handle multiple tasks.
  • Ability to work autonomously and make decisions; ability to produce correct results.
  • Proven leadership and project management skills.
  • Experience managing people, providing learning opportunities and professional growth.

Physical Demands/Working Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to see, hear, talk, and use hands and fingers to handle or feel. The employee is required to sit for long periods of time and is occasionally required to stand, walk, and reach with arms. Specific vision abilities required include close vision and the ability to adjust focus. While performing the duties of this job, the employee is most often in an office setting where the noise level is typically low.

The employee must be able to travel.

Please direct inquiries to jobs@molecularassemblies.com